Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: INTEGRA DERMAL REGENERATION TEMPLATE - TERMINALLY STERILIZED (IDRT-TS)
• Generic Name: Device, dermal replacement
• Applicant: Integra Lifesciences Corp.; 105 Morgan Ln.; Plainsboro, NJ 08536
• PMA Number: P900033
• Supplement Number: S021
• Date Received: 10/13/2011
• Decision Date: 05/24/2012
• Product Codes: MDD MGR
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH AST, LLC IN DENVER, COLORADO.