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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCOLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable collagen hemostatic agents
Regulation Number878.4490
ApplicantINTEGRA LIFESCIENCES CORP.
PMA NumberP810006
Supplement NumberS022
Date Received09/30/2005
Decision Date09/20/2006
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at integra neurosciences pr, inc. , anasco, puerto rico for packaging and steri-tech, inc. , salinas, puerto rico for sterilization.
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