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: SURGILENE
• Generic Name: Suture, nonabsorbable, synthetic, polyethylene
• Regulation Number: 878.5000
• Applicant: Davis & Geck, Inc.; American Cynamid Company; One Casper St.; Danbury, CT 06810
• PMA Number: N17825
• Supplement Number: S012
• Date Received: 07/08/1981
• Decision Date: 06/30/1983
• Product Code: GAT
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No