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: COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED)
• Generic Name: Suture, absorbable
• Regulation Number: 878.4830
• Applicant: ETHICON, Inc.; P.O Box 151, Rte. 22 W.; Somerville, NJ 08876
• PMA Number: N18176
• Supplement Number: S001
• Date Received: 04/02/1980
• Decision Date: 05/02/1980
• Product Code: GAK
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No