FDA Premarket Approval Database

$447.50 / year

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing clearance.

Complexity

PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application 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.

Date Created

2013

Last Modified

2020-09-15

Version

2020-09-15

Update Frequency

Monthly

Temporal Coverage

1960 to 2020-09-15

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

NameDescriptionTypeConstraints
PMA_NumberPremarket Approval Numberstring-
Supplement_NumberPMA Supplement Numberstring-
ApplicantThe Name of the applicantstring-
Address_Line_1The Address of the applicantstring-
Address_Line_2Second part of the Address of the applicantstring-
CityThe City of the applicantstring-
State_AbbreviationThe State of the applicantstring-
Zip_CodeThe Zip code of the applicantstring-
Zip_ExtensionThe zip code extension of the applicantstring-
Generic_NameGeneric Name of the productstring-
Trade_NameTrade Name of the productstring-
Product_CodeProduct Code Classificationstring-
Advisory_CommitteeAdvisory Committeestring-
Supplement_TypeType of Supplementstring-
Supplement_ReasonPrimary Reason for Supplementstring-
Is_Review_GrantedExpedited Review Grantedstring-
Received_DateDate Receiveddate-
Decision_DatePMA date decisiondate-
Docket_NumberDocket numberstring-
Fed_Reg_Notice_DateDate of federal register noticedate-
Decision_CodeFDA decision codestring-
Approval_Order_StatementFDA approval order statementstring-
PMA NumberSupplement NumberApplicantAddress Line 1Address Line 2CityState AbbreviationZip CodeZip ExtensionGeneric NameTrade NameProduct CodeAdvisory CommitteeSupplement TypeSupplement ReasonIs Review GrantedReceived DateDecision DateDocket NumberFed Reg Notice DateDecision CodeApproval Order Statement
P160006VENTANA MEDICAL SYSTEMS, INC.1910 EAST INNOVATION PARK DR.TUCSONAZ85755Immunohistochemistry assay, antibody, programmed death-ligand 1VENTANA PD-L1 (SP142) AssayPLSPATrue2016-02-222016-10-1816M-34312016-11-15APCBApproval 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).
P150047Roche Molecular Systems, Inc.4300 Hacienda DrivePleasantonCA945882722.0Somatic gene mutation detection systemcobas EGFR MUTATION TEST v2OWDPATrue2015-12-092016-06-0116M-14592016-06-06APCBApproval 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.
P150044Roche Molecular Systems, Inc.4300 Hacienda DrivePleasantonCA945882722.0Somatic gene mutation detection systemcobas EGFR MUTATION TEST v2OWDPATrue2015-11-232016-09-2816M-29732016-10-10APCBThe 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.
P150027DAKO NORTH AMERICA, INC.6392 VIA REALCARPINTERIACA93013Immunohistochemistry assay, antibody, programmed death-ligand 1PD-L1 IHC 28-8 pharmDxPLSPAFalse2015-08-042016-01-2316M-08032016-03-03APCBAPPROVAL 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.
P940022ADVANCED BIONICS CORP.12740 SAN FERNANDO RD.SYLMARCA91342Implant, cochlearCLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANTMCMENFalse1994-06-301996-03-2296M-04901996-12-27APCBAPPROVAL FOR THE CLARION MULTI-STRATEGY COCHLEAR IMPLANT FOR USE IN AN ADULT POPLUATION
P810005CIBA VISION CARE11460 JOHNS CREEK PKWY.DULUTHGA301361518.0Lenses, soft contact, extended wearWEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENSLPMOPFalse1981-02-201981-09-2481M-03171981-11-03APCB
P050022SIEMENS MEDICAL SOLUTIONS USA, INC.51 VALLEY STREAM PKWY.,MAIL STOP E-51MALVERNPA19355Lung computed tomography system, computer-aided diagnosisSYNGO LUNG CADNRRRAFalse2005-06-302006-10-1806M-04562006-11-08APCBAPPROVAL FOR THE SYNGO LUNG CAD SOFTWARE DEVICE. THE DEVICE IS INDICATED TO ASSIST RADIOLOGISTS IN THE DETECTION OF SOLID PULMONARY NODULES DURING REVIEW OF MULTI-DETECTOR COMPUTED TOMOGRAPHY (MDCT) EXAMINATIONS OF THE CHEST. THE SOFTWARE IS AN ADJUNCTIVE TOOL TO ALERT THE RADIOLOGIST TO REGIONS OF INTEREST (ROI) THAT MAY HAVE BEEN INITIALLY OVERLOOKED. THE LUNG CAD SOFTWARE DEVICE IS INTENDED TO BE USED AS A SECOND READER AFTER THE RADIOLOGIST HAS COMPLETED HIS/HER INITIAL READ.
P030012HOLOGIC, INC.35 CROSBY DR.BEDFORDMA1730Lung computed tomography system, computer-aided diagnosisIMAGECHECKER CT CAD SOFTWARE SYSTEMNRRRAFalse2003-04-162004-07-0804M-03232004-07-22APCBAPPROVAL 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.
P020002HOLOGIC, INC.250 Campus DriveMarlboroughMA1752READER, CERVICAL CYTOLOGY SLIDE, AUTOMATEDTHINPREP (R) IMAGING SYSTEMMNMPAFalse2002-01-072003-06-0603M-03392003-07-30APCBAPPROVAL 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.
P160009iCAD Inc98 Spitbrook Road, Suite 100NashuaNH3062Analyzer, medical imagePowerLook Tomo Detection SoftwareMYNRAFalse2016-04-052017-03-2417M-19502017-03-29APRLApproval for the iCAD PowerLook Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE Senoclaire breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation.The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.