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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.
 
DeviceNOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantDatascope Corp.
14 PHILIPS PKWY.
MONTVALE, NJ 07645
PMA NumberP850023
Supplement NumberS006
Date Received10/22/1987
Decision Date09/09/1988
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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