Others titles

MD Premarket Approval in the United States
Medical Device Premarket Approval

Keywords

Premarket Approval
PMA Approvals
US Premarket
FDCA
FDA Device
CDRH and Applicants
CDRH’s Post-Approval Studies
Post-Approval Studies
Meical Devices
Post-Approval Device

FDA Premarket Approval Database

Name: FDA Premarket Approval Database
Creator: John Snow Labs

This dataset includes the Premarket Approval (PMA) data which is the Food and Drug Administration (FDA) process of scientific and regulatory review to assess the safety and effectiveness of Class III medical devices. These devices support human life and prevent impairment of human health. Due to the level of risk associated with Class III devices, general and special controls are insufficient to assure the safety of these devices and require a PMA application to obtain marketing clearance.

Complexity

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Description

Premarket Approval (PMA) is the most stringent type of device marketing application required by Food and Drug Administration (FDA). The applicant must receive FDA approval of its PMA application under section 515 of the Food, Drug, and Cosmetic (FD&C) Act prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s). An approved PMA is, in effect, a private license granting the applicant (or owner) permission to market the device. The PMA owner, however, can authorize use of its data by another.

The PMA applicant is usually the person who owns the rights, or otherwise has authorized access, to the data and other information to be submitted in support of FDA approval. This person may be an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or other legal entity. The applicant is often the inventor/developer and ultimately the manufacturer.

FDA regulations provide 180 days to review the PMA and make a determination. In reality, the review time is normally longer. Before approving or denying a PMA, the appropriate FDA advisory committee may review the PMA at a public meeting and provide FDA with the committee’s recommendation on whether FDA should approve the submission. After FDA notifies the applicant that the PMA has been approved or denied, a notice is published on the Internet (1) announcing the data on which the decision is based, and (2) providing interested persons an opportunity to petition FDA within 30 days for reconsideration of the decision.

About this Dataset

Data Info

Date Created	2013
Last Modified	2023-01-15
Version	2023-01-15
Update Frequency	Monthly
Temporal Coverage	1960 to 2023-01-15
Spatial Coverage	United States
Source	John Snow Labs; Food and Drug Administration (FDA);
Source License URL
Source License Requirements	N/A
Source Citation	N/A
Keywords	Premarket Approval, PMA Approvals, US Premarket, FDCA, FDA Device, CDRH and Applicants, CDRH’s Post-Approval Studies, Post-Approval Studies, Meical Devices, Post-Approval Device
Other Titles	MD Premarket Approval in the United States, Medical Device Premarket Approval

Data Fields

Name	Description	Type	Constraints
PMA_Number	Premarket Approval Number	string	-
Supplement_Number	PMA Supplement Number	string	-
Applicant	The Name of the applicant	string	-
Address_Line_1	The Address of the applicant	string	-
Address_Line_2	Second part of the Address of the applicant	string	-
City	The City of the applicant	string	-
State_Abbreviation	The State of the applicant	string	-
Zip_Code	The Zip code of the applicant	string	-
Zip_Extension	The zip code extension of the applicant	string	-
Generic_Name	Generic Name of the product	string	-
Trade_Name	Trade Name of the product	string	-
Product_Code	Product Code Classification	string	-
Advisory_Committee	Advisory Committee	string	-
Supplement_Type	Type of Supplement	string	-
Supplement_Reason	Primary Reason for Supplement	string	-
Is_Review_Granted	Expedited Review Granted	string	-
Received_Date	Date Received	date	-
Decision_Date	PMA date decision	date	-
Docket_Number	Docket number	string	-
Fed_Reg_Notice_Date	Date of federal register notice	date	-
Decision_Code	FDA decision code	string	-
Approval_Order_Statement	FDA approval order statement	string	-

Data Preview

PMA Number

Supplement Number

Applicant

Address Line 1

Address Line 2

City

State Abbreviation

Zip Code

Zip Extension

Generic Name

Trade Name

Product Code

Advisory Committee

Supplement Type

Supplement Reason

Is Review Granted

Received Date

Decision Date

Docket Number

Fed Reg Notice Date

Decision Code

Approval Order Statement

P160006

VENTANA MEDICAL SYSTEMS, INC.

1910 EAST INNOVATION PARK DR.

TUCSON

85755

Immunohistochemistry assay, antibody, programmed death-ligand 1

VENTANA PD-L1 (SP142) Assay

PLS

True

2016-02-22

2016-10-18

16M-3431

2016-11-15

APCB

Approval for the VENTANA PD-L1 (SP142) Assay. This device is indicated for the following: VENTANA PD-L1 (SP142) Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP142 intended for use in the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) urothelial carcinoma and non-small cell lung cancer (NSCLC) tissue stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a VENTANA BenchMark ULTRA instrument. Determination of PD-L1 status is indication-specific, and evaluation is based on either the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (% IC) of any intensity or the percentage of PD-L1 expressing tumor cells (% TC) of any intensity.PD-L1 expression in 5% IC determined by VENTANA PD-L1 (SP142) Assay in urothelial carcinoma tissue is associated with increased objective response rate (ORR) in a non-randomized study of TECENTRIQ (atezolizumab).PD-L1 expression in 50% TC or 10% IC as detected by VENTANA PD-L1 (SP142) Assay in NSCLC may be associated with enhanced overall survival from TECENTRIQ (atezolizumab).

P150047

Roche Molecular Systems, Inc.

4300 Hacienda Drive

Pleasanton

94588

2722.0

Somatic gene mutation detection system

cobas EGFR MUTATION TEST v2

OWD

True

2015-12-09

2016-06-01

16M-1459

2016-06-06

APCB

Approval for the cobas EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood.The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling.Table 1 Drug FFPET PlasmaTARCEVA (erlotinib) Exon 19 deletions and L858R Exon 19 deletions and L858RTAGRISSO (osimertinib) T790M Patients with positive cobas EGFR Mutation Test v2 test results using plasma specimens for the presence of EGFR exon 19 deletions or L858R mutations are eligible for treatment with TARCEVA (erlotinib). Patients who are negative for these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.Drug safety and efficacy have not been established for the EGFR mutations listed in Table 2 below that are also detected by the cobas EGFR Mutation Test v2. Table 2 Drug FFPET PlasmaTARCEVA (erlotinib) G719X, exon 20 insertions, T790M, S768I and L861Q G719X, exon 20 insertions, T790M, S768I and L861QTAGRISSO (osimertinib) G719X, exon 19 deletions, L858R, exon 20 insertions, S768I, and L861Q G719X, exon 19 deletions, L858R, exon 20 insertions, T790M, S768I, and L861QFor manual sample preparation, FFPET specimens are processed using the cobas DNA Sample Preparation Kit and plasma specimens are processed using the cobas cfDNA Sample Preparation Kit. The cobas z 480 analyzer is used for automated amplification and detection.

P150044

Roche Molecular Systems, Inc.

4300 Hacienda Drive

Pleasanton

94588

2722.0

Somatic gene mutation detection system

cobas EGFR MUTATION TEST v2

OWD

True

2015-11-23

2016-09-28

16M-2973

2016-10-10

APCB

The cobas EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood.The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling:Table 1Drug FFPET PlasmaTARCEVA (erlotinib) Exon 19 deletions and L858R Exon 19 deletions and L858RTAGRISSO (osimertinib) 790M T790M*Patients with positive cobas EGFR Mutation Test v2 test results using plasma specimens for the presence of the EGFR mutations listed above are eligible for treatment with the corresponding drug as indicated in Table 1 (see Note* for T790M). Patients who are negative for these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type. *The efficacy of TAGRISSO (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore, testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.Drug safety and efficacy have not been established for the EGFR mutations listed in Table 2 below that are also detected by the cobas EGFR Mutation Test v2: Table 2Drug FFPET PlasmaTARCEVA (erlotinib) G719X, exon 20 insertions, T790M, S768I and L861Q G719X, exon 20 insertions, T790M, S768I and L861QTAGRISSO (osimertinib) G719X, exon 19 deletions, L858R, exon 20 insertions, S768I, and L861Q G719X, exon 19 deletions, L858R, exon 20 insertions, S768I, and L861QFor manual sample preparation, FFPET specimens are processed using the cobas DNA Sample Preparation Kit and plasma specimens are processed using the cobas cfDNA Sample Preparation Kit. The cobas z 480 analyzer is used for automated amplification and detection.

P150027

DAKO NORTH AMERICA, INC.

6392 VIA REAL

CARPINTERIA

93013

Immunohistochemistry assay, antibody, programmed death-ligand 1

PD-L1 IHC 28-8 pharmDx

PLS

False

2015-08-04

2016-01-23

16M-0803

2016-03-03

APCB

APPROVAL FOR THE PD-L1 IHC 28-8 PHARMDX. THIS DEVICE IS INDICATED FOR THE FOLLOWING:PD-L1 IHC 28-8 PHARMDX IS A QUALITATIVE IMMUNOHISTOCHEMICAL ASSAY USING MONOCLONAL RABBIT ANTI-PD-L1, CLONE 28-8 INTENDED FOR USE IN THE DETECTION OF PD-L1 PROTEIN IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) NON-SQUAMOUS NON SMALL CELL LUNG CANCER (NSCLC) AND MELANOMA TISSUE USING ENVISION FLEX VISUALIZATION SYSTEM ON AUTOSTAINER LINK 48. PD-L1 PROTEIN EXPRESSION IS DEFINED AS THE PERCENTAGE OF TUMOR CELLS EXHIBITING POSITIVE MEMBRANE STAINING AT ANY INTENSITY. PD-L1 EXPRESSION AS DETECTED BY PD-L1 IHC PHARMDX IN NONSQUAMOUS NSCLC MAY BE ASSOCIATED WITH ENHANCED SURVIVAL FROM OPDIVO (NIVOLUMAB).POSITIVE PD-L1 STATUS AS DETERMINED BY PD-L1 IHC 28-8 PHARMDX IN MELANOMA IS CORRELATED WITH THE MAGNITUDE OF THE TREATMENT EFFECT ON PROGRESSION-FREE SURVIVAL FROM OPDIVO.

P940022

ADVANCED BIONICS CORP.

12740 SAN FERNANDO RD.

SYLMAR

91342

Implant, cochlear

CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT

MCM

False

1994-06-30

1996-03-22

96M-0490

1996-12-27

APCB

APPROVAL FOR THE CLARION MULTI-STRATEGY COCHLEAR IMPLANT FOR USE IN AN ADULT POPLUATION

P810005

CIBA VISION CARE

11460 JOHNS CREEK PKWY.

DULUTH

30136

1518.0

Lenses, soft contact, extended wear

WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS

LPM

False

1981-02-20

1981-09-24

81M-0317

1981-11-03

APCB

P030012

HOLOGIC, INC.

35 CROSBY DR.

BEDFORD

1730

Lung computed tomography system, computer-aided diagnosis

IMAGECHECKER CT CAD SOFTWARE SYSTEM

NRR

False

2003-04-16

2004-07-08

04M-0323

2004-07-22

APCB

APPROVAL FOR THE IMAGECHECKER CT CAD SOFTWARE SYSTEM - MODEL LN-1000. THIS SOFTWARE SYSTEM IS INDICATED TO ASSIST RADIOLOGISTS IN THE DETECTION OF SOLID PULMONARY NODULES DURING REVIEW OF MULTIDETECTOR CT (MDCT) SCANS OF THE CHEST. IT IS INTENDED TO BE USED AS AN ADJUNCT, ALERTING THE RADIOLOGIST - AFTER HIS OR HER INITIAL READING OF THE SCAN - TO REGIONS OF INTEREST (ROIS) THAT MAY HAVE BEEN INITIALLY OVERLOOKED.

P020002

HOLOGIC, INC.

250 Campus Drive

Marlborough

1752

READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED

THINPREP (R) IMAGING SYSTEM

MNM

False

2002-01-07

2003-06-06

03M-0339

2003-07-30

APCB

APPROVAL FOR THE THINPREP IMAGING SYSTEM. THE DEVICE IS INDICATED FOR ASSISTING IN PRIMARY CERVICAL CANCER SCREENING OF THINPREP PAP TEST SLIDES FOR THE PRESENCE OF ATYPICAL CELLS, CERVICAL NEOPLASIA, INCLUDING ITS PRECURSOR LESIONS (LOW GRADE SQUAMOUS INTRAEPITHELIAL LESIONS, HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESIONS, AND CARCINOMA AS WELL AS ALL OTHER CYTOLOGICAL CRITERIA AS DEFINED BY THE 2001 BETHESDA SYSTEM: TERMINOLOGY FOR REPORTING RESULTS OF CERVICAL CYTOLOGY.

P190025

Abbott Molecular, Inc.

1300 E. Touhy Avenue

Des Plaines

60018

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus

Alinity m HCV

MZP

False

2019-09-30

2020-03-23

20M-1175

2020-04-07

APRL

Approval for the Alinity m HCV. The assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human plasma (EDTA, Acid Citrate Dextrose) or serum, from HCV antibody positive individuals. The assay is intended for use as an aid in the diagnosis of active HCV infection in individuals with antibody evidence of HCV infection, and to aid in the management of patients with known active HCV infection, including SVR determination.The results from the Alinity m HCV assay must be interpreted within the context of all relevant clinical and laboratory findings.The Alinity m HCV assay is not intended to be used in screening blood, plasma, serum, tissue or tissue donors for HCV.

P190011

DiaSorin Inc.

1951 Northwestern Avenue

Stillwater

55082

285.0

Assay, enzyme linked immunosorbent, hepatitis c virus

LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab

MZO

False

2019-04-22

2019-10-18

APRL

Approval for the LIAISON XL MUREX HCV Ab. The LIAISON XL MUREX HCV Ab is an in vitro chemiluminescent immunoassay for the qualitative determination of specific antibodies to hepatitis C virus (anti-HCV) in human adult and pediatric serum and plasma (lithium and sodium heparin, sodium citrate and potassium EDTA) samples including separator tubes, on the LIAISON XL Analyzer. It is intended to be used as an aid in the diagnosis of HCV infection. The assay may also be used as an aid in the diagnosis of HCV infection in pediatric subjects and in pregnant women. The test does not determine the state of infection or associated disease. The assay is not intended for use in screening blood, plasma, or tissue donors.The LIAISON XL MUREX Control HCV Ab (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON XL Murex HCV AB assay. The performance characteristics of LIAISON Controls have not been established for any other assays or instrument platforms different from LIAISON XL.