Post-Approval Studies (PAS)
The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.
OSB Lead-Device failure Study
OSB Lead-Device failure Study Schedule
* Sponsor is reporting failure study data in the regular PMA Annual Report.
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
Phone: (301) 796-6134
Fax: (301) 847-8140