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: SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP
• Generic Name: Suture, nonabsorbable, silk
• Regulation Number: 878.5030
• Applicant: ETHICON, Inc.; Rte. 22 W.; Somerville, NJ 08876
• PMA Number: N11397
• Supplement Number: S021
• Date Received: 11/02/1982
• Decision Date: 03/15/1983
• Product Code: GAP
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No