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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 Namehemostatic agent
Regulation Number878.4490
ApplicantINTEGRA LIFESCIENCES CORP.
PMA NumberP810006
Supplement NumberS020
Date Received06/08/2001
Decision Date07/05/2001
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the removal of the neurological exclusion from the indications statement.
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