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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
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
Applicant
BAXTER HEALTHCARE CORP.
32650 n wilson rd
round lake, IL 60073
PMA NumberP990009
Supplement NumberS018
Date Received02/13/2006
Decision Date12/01/2006
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED IN HAYWARD, CALIFORNIA.
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