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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 AGENTS
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable collagen hemostatic agents
Regulation Number878.4490
ApplicantINTEGRA LIFESCIENCES CORP.
PMA NumberP810006
Supplement NumberS027
Date Received01/12/2007
Decision Date02/09/2007
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate alkali treatment production area.
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