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: PDS(TM) SUTURE (CLEAR)
• Generic Name: Suture, absorbable, synthetic, polyglycolic acid
• Regulation Number: 878.4493
• Applicant: ETHICON, Inc.; P.O Box 151, Rte. 22 W.; Somerville, NJ 08876
• PMA Number: N18387
• Supplement Number: S006
• Date Received: 03/04/1982
• Decision Date: 07/21/1982
• Product Code: GAM
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No