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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 ABSORABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR FORM
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable collagen hemostatic agents
Regulation Number878.4490
ApplicantINTEGRA LIFESCIENCES
PMA NumberP810006
Supplement NumberS043
Date Received05/28/2013
Decision Date06/26/2013
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Replacement of air handling units.
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