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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(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable collagen hemostatic sponge
Regulation Number878.4490
ApplicantAMERICAN BIOMATERIALS CORP.
PMA NumberP850010
Supplement NumberS001
Date Received12/13/1985
Decision Date01/17/1986
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
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