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 Artificial Skin Dermal Regeneration Template
• Generic Name: Dressing, wound and burn, interactive
• Applicant: Integra Lifesciences Corp.; 105 Morgan Ln.; Plainsboro, NJ 08536
• PMA Number: P900033
• Supplement Number: S057
• Date Received: 08/24/2016
• Decision Date: 09/22/2016
• Product Code: MGR
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
New Tyvek heat sealer and sealing parameters.