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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameFLOSEAL HEMOSTATIC MATRIX
Classification Nameagent, absorbable hemostatic, collagen based
Generic Namefusion matrix-dry
Regulation Number878.4490
ApplicantBAXTER HEALTHCARE CORP.
PMA NumberP990009
Supplement NumberS034
Date Received03/14/2012
Decision Date07/25/2012
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the following changes to the floseal hemostatic matrix 10ml kit configuration: inclusion of malleable tip; applicator; modified bowl; pre-filled syringe of sodium chloride solution; vial of thrombin (5000 units); and inclusion of a needle-free vial adapter.
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