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 SUTURE NONABSORBABLE SURG. S
• Generic Name: Suture, nonabsorbable, synthetic, polyethylene
• Regulation Number: 878.5000
• Applicant: ETHICON, Inc.; Rte. 22 W.; Somerville, NJ 08876
• PMA Number: N16374
• Supplement Number: S033
• Date Received: 08/12/1987
• Decision Date: 08/28/1987
• Product Code: GAT
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No