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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.
 
DeviceEVOLENCE COLLAGEN FILLER
Generic NameImplant, dermal, for aesthetic use
ApplicantCOLBAR LIFESCIENCE LTD.
9 HAMENOFIM ST.
HERZLIYA 46733
PMA NumberP070013
Supplement NumberS005
Date Received09/30/2008
Decision Date10/31/2008
Withdrawal Date 12/03/2010
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
INCREASE PRODUCTION SCALE OF PURIFIED COLLAGEN DURING THE MANUFACTURING OF THE DEVICE.
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