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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHEMOPAD(TM) ABSORBABLE COLLAGEN HEMOSTAT
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantDatascope Corp.
14 PHILIPS PKWY.
MONTVALE, NJ 07645
PMA NumberP850023
Supplement NumberS010
Date Received07/12/1991
Decision Date11/16/1992
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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