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Premarket Approval Application

Known as: Premarket Approval 
National Institutes of Health

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Premarket Device Application

Papers overview

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2018
2018
Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom. Final order.
The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify single-use female condoms, renaming… 
2016
2016
Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair. Final order.
The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of a premarket approval… 
2013
2013
Cardiovascular devices; reclassification of external counter-pulsating devices for treatment of chronic stable angina; effective date of requirement for premarket approval for external counter…
The Food and Drug Administration (FDA) is issuing a final order to reclassify external counter-pulsating (ECP) devices for… 
2012
2012
Effective date of requirement for premarket approval for a pacemaker programmer. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or… 
2008
2008
Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. Final rule.
The Food and Drug Administration (FDA) is amending its regulations regarding changes to an approved new drug application (NDA… 
2006
2006
Ventricular Assist Devices
Review
1998
Review
1998
Medical devices; 30-day notices and 135-day PMA (premarket approval application) supplement review--FDA. Direct final rule.
The Food and Drug Administration (FDA) is amending its regulations governing the submission and review of premarket approval… 
1998
1998
Dental devices; effective date of requirement for premarket approval; temporomandibular joint prostheses--FDA. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or… 
1994
1994
The role of clinical trials in the Food and Drug Administration approval process for cardiovascular devices.
T he Food, Drug and Cosmetic Act of 1938 (the Act) required manufacturers to provide evidence of safety to the Food and Drug… 
1986
1986
General hospital and personal use devices; premarket approval of the infant radiant warmer--FDA. Proposed rule.
The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice…