Skip to search formSkip to main contentSkip to account menu

Premarket Approval Application

Known as: Premarket Approval 
National Institutes of Health

Related topics

Related topics

1 relation
Premarket Device Application

Papers overview

Semantic Scholar uses AI to extract papers important to this topic.
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… 
Review
2014
Review
2014
Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix® drug coated balloon.
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… 
Review
2002
Review
2002
Regulatory issues in tumor marker development.
The Food and Drug Administration (FDA) has been actively involved in oversight of medical devices, including in vitro diagnostic… 
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… 
Review
1998
Review
1998
Medical devices containing materials derived from animal sources (except for in vitro diagnostic devices), guidance for FDA reviewers and industry; availability--FDA. Notice.
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Medical Devices Containing… 
1997
1997
Clinical trials on placement of implants in existing bone.
The use of dental implants has become a predictable and frequently used treatment modality in partially and fully edentulous… 
1995
1995
An introduction to the food and drug administration and how it evaluates new devices: Establishing safety and efficacy
Most physicians, and certainly the lay public, have only limited knowledge of the responsibilities and limits of the Food and… 
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… 
By clicking accept or continuing to use the site, you agree to the terms outlined in our Privacy Policy (opens in a new tab), Terms of Service (opens in a new tab), and Dataset License (opens in a new tab)