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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 SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantINTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536
PMA NumberP810006
Supplement NumberS034
Date Received08/23/2012
Decision Date09/14/2012
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN CHART RECORDING SYSTEM.
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