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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
Classification Nameagent, absorbable hemostatic, collagen based
Generic Namehemostatic agent
Regulation Number878.4490
ApplicantINTEGRA LIFESCIENCES CORP.
PMA NumberP810006
Supplement NumberS002
Date Received02/11/1982
Decision Date04/12/1982
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
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