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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 (R) ABSORBABLE COLLAGEN HEMOSTATIC AGENT
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agents, collagen based
Regulation Number878.4490
ApplicantINTEGRA LIFESCIENCES CORP.
PMA NumberP850010
Supplement NumberS015
Date Received07/26/1995
Decision Date09/12/1995
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate sterilization facility for helistat absorbable collagen hemostatic agent at griffith microscience, inc. 27 park road, glen falls, ny 12801.
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