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: NON-ABSORBABLE SUTURES NYLON
• Generic Name: Suture, nonabsorbable, synthetic, polyamide
• Regulation Number: 878.5020
• Applicant: Davis & Geck, Inc.; 1 Casper St.; Danbury, CT 06810
• PMA Number: N83511
• Supplement Number: S002
• Date Received: 08/26/1981
• Decision Date: 10/20/1981
• Product Code: GAR
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No