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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFLOSEAL MATRIX(R)/PROCEED(R) HEMOSTATIC SEALANTS (DRY FORM)
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantBAXTER HEALTHCARE CORP.
32650 N WILSON RD
ROUND LAKE, IL 60073
PMA NumberP990009
Supplement NumberS009
Date Received06/26/2001
Decision Date08/10/2001
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN INCREASE IN AN INTERMEDIATE SPECIFICATION FOR RESIDUAL GLUTARALDEHYDE FROM 20 TO 40 PPM, THE REMOVAL OF THE NEUROSURGICAL EXCLUSION FROM THE INDICATIONS STATEMENT AND THE ADDITION OF THE NASAL/SINUS INSTRUCTIONS AND INORMATION TO THE LABELING OF THE "DRY" FORM OF THE FUSION MATRIX PRODUCT.
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