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: GORE-TEX(R) EXPANDED PTFE SUTURE
• Generic Name: Suture, nonabsorbable, synthetic, polypropylene
• Regulation Number: 878.5010
• Applicant: W. L. Gore & Associates, Inc.; 1500 N. Fourth St.; P.O. Box 3000; Flagstaff, AZ 86003
• PMA Number: P820083
• Supplement Number: S008
• Date Received: 10/18/1988
• Decision Date: 05/02/1989
• Product Code: GAW
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No