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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Perigee AE and Eff Rates


 
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General
Study Status Other
522 Number / Requirement Number PS120010 / PSS002
Date Original Plan Accepted 03/08/2012
Study Name Perigee AE and Eff Rates
Device Name Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix, ams apogee system with pre-connected collagen dermal matrix, ams perigee system with pre-connected collagen dermal matrix
Root Document Number K082730 
General Study Protocol Parameters
Study Population
Detailed Study Protocol Parameters
Study Objectives The manufacturer ceased market distribution of the device subject to the postmarket surveillance order. If manufacturer resumes device distribution they will be required to address the postmarket surveillance order.




Contact Us


Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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