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.
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Last updated:January 20, 2021
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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
2025-05-15
Version
2025-05-15
Update Frequency
Monthly
Temporal Coverage
1960 to 2025-05-15
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
P890055
S029
Intera Oncology
180 Wells Ave, Suite 300A
Newton
MA
02459
Pump, infusion, implanted, programmable
MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
LKK
HO
Normal 180 Day Track No User Fee
Postapproval Study Protocol - OSB
False
2011-01-18
2011-03-15
APPR
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P890055
S030
Intera Oncology
180 Wells Ave, Suite 300A
Newton
MA
02459
Pump, infusion, implanted, programmable
MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
LKK
HO
Normal 180 Day Track No User Fee
Postapproval Study Protocol - OSB
False
2011-01-18
2011-03-15
APPR
APPROVAL OF THE POST-APPROVAL PROTOCOL.
P890055
S031
Intera Oncology
180 Wells Ave, Suite 300A
Newton
MA
02459
Pump, infusion, implanted, programmable
MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
LKK
HO
Normal 180 Day Track
Change Design/Components/Specifications/Material
False
2011-01-18
2013-02-12
APPR
APPROVAL FOR MODIFICATIONS TO THE MEDSTREAM REFILL KIT AND O.R. PREP KIT. THE PMA SUPPLEMENT ALSO REQUESTED APPROVAL FOR STERILIZATION TO OCCUR AT STERIS ISOMEDIX SERVICES IN NORTHBOROUGH, MASSACHUSETTS AND KIT PACKAGING TO OCCUR AT CONTECH MEDICAL, INC., IN PROVIDENCE, RHODE ISLAND.
P980037
S034
Boston Scientific Corp.
One Scimed Place
Maple Grove
MN
55311
1566.0
CATHETER, CORONARY, ATHERECTOMY
ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
MCX
CV
Real-Time Process
Change Design/Components/Specifications/Material
False
2011-01-18
2011-03-17
APPR
APPROVAL FOR CHANGES TO THE ANGIOJET ULTRA CONSOLE SOFTWARE.
P070009
S011
OBTECH MEDICAL GMBH
LANDIS AND GYR STRASSE 1
ZUG
CH-63
6300.0
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
REALIZE ADJUSTABLE GASTRIC BAND
LTI
GU
Normal 180 Day Track
Change Design/Components/Specifications/Material
False
2011-01-18
2011-07-15
APPR
APPROVAL FOR THE REALIZE PRESSURE RECORDING SYSTEM, INDICATED TO RECORD AND DISPLAY FLUID PRESSURE VARIATIONS WITHIN A CLOSED SYSTEM BY CONVERTING MECHANICAL INPUTS TO ANALOG/DIGITAL ELECTRICAL SIGNALS.
P850007
S031
Orthofix, Inc.
3451 Plano Parkway
Lewisville
TX
75056
Stimulator, bone growth, non-invasive
SPINAL-STIM SPINAL FUSION SYSTEM
LOF
OR
Real-Time Process
Change Design/Components/Specifications/Material
False
2011-01-19
2011-03-11
APPR
APPROVAL FOR DESIGN MODIFICATIONS TO THE GARMENT COVERING, THE TREATMENT COILS, LIQUID CRYSTAL DISPLAY, CONTROL UNIT HOUSING PROFILE, ORIENTATION OF THE CONTROLS, SOFTWARE/ FIRMWARE, POWER SUPPLY CORD, AND LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPINAL-STIM AND IS INDICATED AS A SPINAL FUSION ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS AND AS A NON-OPERATIVE TREATMENT FOR SALVAGE OF FAILED SPINAL FUSION, WHERE A MINIMUM OF NINE MONTHS HAS ELAPSED SINCE THE LAST SURGERY.
P030034
S005
Orthofix, Inc.
3451 Plano Parkway
Lewisville
TX
75056
Stimulator, bone growth, non-invasive
CERVICAL-STIM CERVICAL FUSION SYSTEM
LOF
OR
Real-Time Process
Change Design/Components/Specifications/Material
False
2011-01-19
2011-03-11
APPR
APPROVAL FOR DESIGN MODIFICATIONS TO THE GARMENT COVERING, THE TREATMENT COILS, LIQUID CRYSTAL DISPLAY, CONTROL UNIT HOUSING PROFILE, ORIENTATION OF THE CONTROLS, SOFTWARE/ FIRMWARE, POWER SUPPLY CORD, AND LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CERVICAL-STIM AND IS INDICATED AS AN ADJUNCT TO CERVICAL FUSION SURGERY IN PATIENTS AT HIGH RISK FOR NON-FUSHION.
APPROVAL FOR PHYSICIAN AND PATIENT LABELING REVISIONS TO INCLUDE INFORMATION ABOUT ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) AND CONNECTIVE TISSUE DISEASE (CTD) RISKS WITH THE NATRELLE SALINE-FILLED BREAST IMPLANT.
P010031
S232
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW
MN
55112
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT
APPROVAL FOR A MODIFICATION TO THE INDICATIONS FOR USE AS FOLLOWS.FOR THE CONCERTO CRT-D MODEL C154DWK, CONSULTA CRT-D MODEL D224TRK, CONCERTO II CRT-D MODEL D274TRK, PROTECTA CRT-D MODEL D334TRG, PROTECTA CRT-D MODEL D334TRM, PROTECTA XT CRT-D MODEL D314TRG, PROTECTA XT CRT-D MODEL D314TRM, AND CONSULTA CRT-D MODEL D204TRM CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) THE INDICATIONS FOR USE ARE: THE CRT-D SYSTEM IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIASAND FOR PROVIDING CARDIAC RESYNCHRONIZATION THERAPY IN HEART FAILURE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE OPTIMAL MEDICAL THERAPY, AND MEET ANY OF THE FOLLOWING CLASSIFICATIONS: 1) NEW YORK HEART ASSOCIATION (NYHA) FUNCTIONAL CLASS III OR IV AND WHO HAVE A LEFT VENTRICULAR EJECTION FRACTION <= 35% AND A PROLONGED QRS DURATION. 2) LEFT BUNDLE BRANCH BLOCK (LBBB) WITH A QRS DURATION >= 130 MS, LEFT VENTRICULAR EJECTIONFRACTION <= 30%, AND NYHA FUNCTIONAL CLASS II. THE SYSTEM IS ALSO INDICATED FOR USE IN PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK FOR DEVELOPING ATRIAL TACHYARRHYTHMIAS. ATRIAL RHYTHM MANAGEMENT FEATURES SUCH AS ATRIAL RATE STABILIZATION (ARS), ATRIAL PREFERENCE PACING (APP), AND POST MODE SWITCH OVERDRIVE (PMOP) ARE INDICATED FOR THE SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS IN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)-INDICATED PATIENTS WITH ATRIAL SEPTAL LEAD PLACEMENT AND AN ICD INDICATION. FOR THE MAXIMO II CRT-D MODEL D284TRK AND MAXIMO IICRT-D MODEL D264TRM CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) THE INDICATIONS FOR USE ARE: (FOR ADDITIONAL INFORMATION, PLEASE SEE APPROVAL ORDER.)
P910077
S110
BOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul
MN
55112
Implantable cardioverter defibrillator (non-CRT)
LATITUDE PATIENT MANAGEMENT SYSTEM
LWS
CV
Real-Time Process
Change Design/Components/Specifications/Material
False
2011-01-24
2011-03-03
APPR
APPROVAL FOR MODIFICATION TO THE LATITUDE PATIENT MANAGEMENT SYSTEM REGULATED APPLICATION SOFTWARE V7.0.02 ON LATITUDE SYSTEM SERVER (MODEL 6488) AND RELATED COMMUNICATOR SOFTWARE CHANGES (MODEL 6476).
Demos
