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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 NameHELISTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT HELITENE ABSORABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORM
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agents, collagen based
Regulation Number878.4490
ApplicantINTEGRA LIFESCIENCES CORPORATION
PMA NumberP850010
Supplement NumberS049
Date Received12/20/2013
Decision Date01/17/2014
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 to introduce an alternate test method for bacterial endotoxin in collagen products.
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