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

2019-03-15

Version

2019-03-15

Update Frequency

Monthly

Temporal Coverage

1960 to 2019-03-15

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
N17433DAVIS & GECK, INC.ONE CASPER ST.DANBURYCT06810PRE OP SPONGEHOfalse1973-01-151978-10-12APPR
N17755S019ZIMMER, INC.P.O. Box 708WarsawIN465810708BONE CEMENTBONECEMENTLODORfalse1980-09-011981-02-26APPR
N17755S021ZIMMER, INC.P.O. Box 708WarsawIN465810708BONE CEMENTBONECEMENTLODORfalse1981-05-221981-06-16APPR
N17755S022ZIMMER, INC.P.O. Box 708WarsawIN465810708BONE CEMENTBONECEMENTLODORfalse1981-06-291981-09-01APPR
N17755S024ZIMMER, INC.P.O. Box 708WarsawIN465810708BONE CEMENTBONECEMENTLODORfalse1982-02-111982-07-23APPR
N17755S025ZIMMER, INC.P.O. Box 708WarsawIN465810708BONE CEMENTBONECEMENTLODORfalse1982-07-071982-07-27APPR
N17755S026ZIMMER, INC.P.O. Box 708WarsawIN465810708BONE CEMENTBONECEMENTLODORfalse1982-08-061982-09-29APPR
N17755S027ZIMMER, INC.P.O. Box 708WarsawIN465810708BONE CEMENTBONECEMENTLODORfalse1982-08-181982-09-22APPR
N17755S028ZIMMER, INC.P.O. Box 708WarsawIN465810708BONE CEMENTBONECEMENTLODORfalse1982-10-261982-11-23APPR
N17755S029ZIMMER, INC.P.O. Box 708WarsawIN465810708BONE CEMENTBONECEMENTLODORfalse1983-01-031983-01-27APPR