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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.
 
DeviceCOLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantIntegra LifeSciences Corporation
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP810006
Supplement NumberS032
Date Received02/02/2009
Decision Date03/26/2009
Product Code 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 ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE PRODUCTION FACILITY LOCATED AT INTEGRA NEUROSCIENCES PR, INC., FOR SEVERAL PRODUCTION STEPS FOR THE DEVICES.
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