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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 HEMOSTATIC MATRIX
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantBaxter Healthcare Corp
32650 N. Wilson Rd.
Round Lake, IL 60073
PMA NumberP990009
Supplement NumberS028
Date Received01/27/2010
Decision Date02/26/2010
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN: 1) THE DRYING CYCLE TIME FRO THE BOVINE GELATIN MANUFACTURING PROCESS; AND 2) THE TEMPERATURE FOR THE GELATIN MANUFACTURING PROCESS.
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