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: HALLMARK ABSORBO ABSORBABLE DUSTING POWDER
• Generic Name: Powder, dusting, surgical
• Applicant: Ingredion Incorporated; 10 Finderne Ave.; Suite C; Bridgewater, NJ 08807
• PMA Number: N80535
• Supplement Number: S001
• Date Received: 03/02/1973
• Decision Date: 03/02/1973
• Withdrawal Date: 10/03/2013
• Product Code: KGP
• Advisory Committee: General Hospital
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Other
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No