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: OXYCEL
• Generic Name: Agent, absorbable hemostatic, non-collagen based
• Regulation Number: 878.4490
• Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic; One Becton Dr.; Franklin Lake, NJ 07417
• PMA Number: N5798
• Supplement Number: S003
• Date Received: 06/29/1982
• Decision Date: 12/17/1982
• Product Code: LMG
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No