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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 NumberS026
Date Received12/12/2006
Decision Date01/09/2007
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 
Change in manufacturing process for a qc release test for finished devices used in the collagen purification process.
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