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: AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)
• Generic Name: Agent, absorbable hemostatic, collagen based
• Regulation Number: 878.4490
• Applicant: C.R. Bard, Inc.; 160 New Boston St.; Woburn, MA 01801
• PMA Number: P800002
• Supplement Number: S010
• Date Received: 12/02/1993
• Decision Date: 09/09/1994
• 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