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: INSTAT COLLAGEN ABSORBABLE HEMOSTAT
• Generic Name: Agent, absorbable hemostatic, collagen based
• Regulation Number: 878.4490
• Applicant: ETHICON, Inc.; Rte. 22 W. P.O. Box 151; Somerville, NJ 08876
• PMA Number: P830079
• Supplement Number: S009
• Date Received: 05/07/1990
• Decision Date: 09/12/1990
• Withdrawal Date: 10/18/2021
• Product Code: LMF
• 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