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: SUPRAMID EXTRA SUTURES
• Generic Name: Suture, nonabsorbable, synthetic, polyamide
• Regulation Number: 878.5020
• Applicant: S. Jackson, Inc.; 15 Roth St.; P.O. Box 4487; Alexandria, VA 22303
• PMA Number: N80838
• Supplement Number: S002
• Date Received: 11/02/1982
• Decision Date: 07/05/1983
• Product Code: GAR
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No