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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 ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agents, collagen based
Regulation Number878.4490
ApplicantINTEGRA LIFESCIENCES CORP.
PMA NumberP850010
Supplement NumberS028
Date Received03/17/2008
Decision Date04/15/2008
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 
Addition of an alternate supplier of bovine deep flexor tendon.
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