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: PROLENE POLYPROPYLENE NONAB.SURG. SUTURE
• Generic Name: Suture, nonabsorbable, synthetic, polyethylene
• Regulation Number: 878.5000
• Applicant: ETHICON, Inc.; Rte. 22 W.; Somerville, NJ 08876
• PMA Number: N16374
• Supplement Number: S022
• Date Received: 02/11/1981
• Decision Date: 06/11/1981
• Product Code: GAT
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No