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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 MATRIX HEMOSTATIC AGENT FLOSEAL ENDOSCOPIC APPLICATOR
Classification Nameagent, absorbable hemostatic, collagen based
Generic Namefusion matrix-dry
Regulation Number878.4490
ApplicantBAXTER HEALTHCARE CORP.
PMA NumberP990009
Supplement NumberS016
Date Received11/15/2004
Decision Date03/31/2005
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product Yes
Recalls CDRH Recalls
Approval Order Statement 
Approval for a modification to the endoscopic applicator and a modification of the "indication for use" for the endoscopic applicator. The device, as modified, will be marketed under the trade name floseal endoscopic applicator and is indicated for use in delivering floseal matrix hemostatic sealant to bleeding surgical sites through a 5 mm or larger trocar.
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