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: VASCUTEK GELSEAL(TM) VASCULAR GRAFT
• Generic Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Regulation Number: 870.3450
• Applicant: Carbomedics, Inc.; 1300-D E. Anderson Ln.; Austin, TX 78752
• PMA Number: P890045
• Supplement Number: S005
• Date Received: 03/31/1994
• Decision Date: 04/13/1995
• Reclassified Date: 05/10/2001
• Product Code: MAL
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No