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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.
 
DevicePERLANE INJECTABLE GEL
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
SEMINARIEGATAN 21
UPPSALA SE-75-752-
PMA NumberP040024
Supplement NumberS006
Date Received03/28/2006
Decision Date05/02/2007
Product Code LMH 
Docket Number 07M-0180
Notice Date 05/11/2007
Advisory Committee General & Plastic Surgery
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE PERLANE INJECTABLE GEL. THE DEVICE IS INDICATED FOR IMPLANTATION INTO THE DEEP DERMIS TO SUPERFICIAL SUBCUTIS FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL FOLDS AND WRINKLES, SUCH AS NASOLABIAL FOLDS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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