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: SUTURES
• Generic Name: Suture, nonabsorbable, silk
• Regulation Number: 878.5030
• Applicant: Sharpoint, Inc.; 824 Twelfth Ave.; Bethlehem, PA 18018
• PMA Number: N85143
• Supplement Number: S001
• Date Received: 12/26/1984
• Decision Date: 10/27/1986
• Product Code: GAP
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No