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: DARDIK BIOGRAFT FOR PERIPHERAL & AV ACCESS USE
• Generic Name: Tissue graft of 6mm and greater
• Applicant: Synovis Surgical Innovations; 2575 University Ave. W.; St. Paul, MN 55114
• PMA Number: P780002
• Supplement Number: S008
• Date Received: 01/24/1990
• Decision Date: 09/11/1990
• Withdrawal Date: 12/13/2007
• Product Code: LXA
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No