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: FLOSEAL HEMOSTATIC MATRIX
• Classification Name: agent, absorbable hemostatic, collagen based
• Generic Name: fusion matrix-dry
• Regulation Number: 878.4490
• Applicant: BAXTER HEALTHCARE CORP.
• PMA Number: P990009
• Supplement Number: S031
• Date Received: 02/14/2011
• Decision Date: 03/16/2011
• Product Code: LMF [ Registered Establishments with LMF ]
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Changes in the manufacturing methods or processes.