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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 hemostatic agents, collagen based
Regulation Number878.4490
ApplicantAMERICAN BIOMATERIALS CORP.
PMA NumberP850010
Supplement NumberS002
Date Received06/19/1986
Decision Date08/18/1986
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type 30-Day Supplement
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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