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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 ENDOSCOPIC APPLICATOR
Classification Nameagent, absorbable hemostatic, collagen based
Generic Namefusion matrix-dry
Regulation Number878.4490
ApplicantBAXTER HEALTHCARE CORP.
PMA NumberP990009
Supplement NumberS027
Date Received12/17/2009
Decision Date02/02/2010
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 No
Approval Order Statement 
Approval for a manufacturing change to remove the etched term floseal from the cannula and some labeling and instructions clarifications.
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