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: DuraSeal Dural Sealant System
• Generic Name: Sealant, dural
• Applicant: Integra LifeSciences Corporation; 311 Enterprise Dr.; Planisboro, NJ 08536
• PMA Number: P040034
• Supplement Number: S032
• Date Received: 08/17/2020
• Decision Date: 09/16/2020
• Product Code: NQR
• Advisory Committee: Neurology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Move the production of the packaging from Building #1 to Building #2.