Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: MICROFIBRILLAR COLLAGEN HEMOSTAT
• Classification Name: agent, absorbable hemostatic, collagen based
• Generic Name: absorbable hemostatic agents, collagen based
• Regulation Number: 878.4490
• Applicant: AVICON, INC.
• PMA Number: N17600
• Supplement Number: S004
• Date Received: 07/21/1980
• Decision Date: 03/31/1981
• Product Code: LMF [ Registered Establishments with LMF ]
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No