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: ABSORBABLE SURGICAL SUTURE, USP
• Generic Name: Suture, absorbable, natural
• Regulation Number: 878.4830
• Applicant: ETHICON, Inc.; Rte. 22 W.; Somerville, NJ 08876
• PMA Number: N10389
• Supplement Number: S023
• Date Received: 10/21/1985
• Decision Date: 06/20/1986
• Product Code: GAL
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No