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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.
 
DeviceNOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
Applicant
Datascope Corp.
14 philips pkwy.
montvale, NJ 07645
PMA NumberP850023
Supplement NumberS001
Date Received08/12/1986
Decision Date09/18/1986
Product Code
LMF
Advisory Committee General & Plastic Surgery
Supplement Type 30-Day Supplement
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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