FDA Premarket Approval Database

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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

2019-10-15

Version

2019-10-15

Update Frequency

Monthly

Temporal Coverage

1960 to 2019-10-15

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
P890055S029CODMAN325 PARAMOUNT DR.RAYNHAMMA02767Pump, infusion, implanted, programmableMEDSTREAM PROGRAMMABLE INFUSION SYSTEMLKKHONormal 180 Day Track No User FeePostapproval Study Protocol - OSBFalse2011-01-182011-03-15APPRAPPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P890055S030CODMAN325 PARAMOUNT DR.RAYNHAMMA02767Pump, infusion, implanted, programmableMEDSTREAM PROGRAMMABLE INFUSION SYSTEMLKKHONormal 180 Day Track No User FeePostapproval Study Protocol - OSBFalse2011-01-182011-03-15APPRAPPROVAL OF THE POST-APPROVAL PROTOCOL.
P890055S031CODMAN325 PARAMOUNT DR.RAYNHAMMA02767Pump, infusion, implanted, programmableMEDSTREAM PROGRAMMABLE INFUSION SYSTEMLKKHONormal 180 Day TrackChange Design/Components/Specifications/MaterialFalse2011-01-182013-02-12APPRAPPROVAL 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.
P980037S034Boston Scientific Corp.One Scimed PlaceMaple GroveMN553111566.0CATHETER, CORONARY, ATHERECTOMYANGIOJET RHEOLYTIC THROMBECTOMY SYSTEMMCXCVReal-Time ProcessChange Design/Components/Specifications/MaterialFalse2011-01-182011-03-17APPRAPPROVAL FOR CHANGES TO THE ANGIOJET ULTRA CONSOLE SOFTWARE.
P070009S011OBTECH MEDICAL GMBHLANDIS AND GYR STRASSE 1ZUGCH-636300.0IMPLANT, INTRAGASTRIC FOR MORBID OBESITYREALIZE ADJUSTABLE GASTRIC BANDLTIGUNormal 180 Day TrackChange Design/Components/Specifications/MaterialFalse2011-01-182011-07-15APPRAPPROVAL 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.
P890055S032CODMAN325 PARAMOUNT DR.RAYNHAMMA02767Pump, infusion, implanted, programmableMEDSTREAM PROGRAMMABLE INFUSION SYSTEMLKKHOReal-Time ProcessChange Design/Components/Specifications/MaterialFalse2011-03-012011-05-10APPRAPPROVAL FOR A NEW ADHESIVE TO SECURE THE ANTENNA AND MODIFICATION TO THE PIEZO ACTUATOR RELEASE SPECIFICATION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDSTREAM PROGRAMMABLE INFUSION SYSTEM AND IS INDICATED FOR THE CHRONIC INTRATHECAL INFUSION OF BACLOFEN INJECTION STERILE SOLUTION (5.0 PH TO 7.0 PH) IN THE TREATMENT OF SEVERE SPASTICITY.
P030034S005Orthofix, Inc.3451 Plano ParkwayLewisvilleTX75056Stimulator, bone growth, non-invasiveCERVICAL-STIM CERVICAL FUSION SYSTEMLOFORReal-Time ProcessChange Design/Components/Specifications/MaterialFalse2011-01-192011-03-11APPRAPPROVAL 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.
P990074S023Allergan2525 DUPONT DR.IRVINECA92612Prosthesis, breast, inflatable, internal, salineNATRELLE SALINE-FILLED BREAST IMPLANTSFWMSUNormal 180 Day Track No User FeeLabeling Change - Indications/instructions/shelf life/tradenameFalse2011-01-242013-09-10APPRAPPROVAL 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.
P010031S232MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 CORAL SEA STREET N.E.MOUNDS VIEWMN55112Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XTNIKCVPanel TrackLabeling Change - Indications/instructions/shelf life/tradenameFalse2011-01-242012-04-0412M-08142012-07-31APPRAPPROVAL 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.)
P050046S009GUIDANT CORP.4100 HAMLINE AVENUE NORTHST. PAULMN551125798.0Permanent defibrillator electrodesACUITY STEERABLE STYLET ACCESSORYNVYCV135 Review Track For 30-Day NoticeProcess Change - Manufacturer/Sterilizer/Packager/SupplierFalse2011-01-262011-06-29APPRAPPROVAL FOR ACCEPTANCE OF A CHANGE TO RELOCATE A SENSOR ON WIRE GRINDING EQUIPMENT AND FORMALIZE INSPECTIONS AS ACCEPTANCE ACTIVITIES.