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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.
 
DevicePERLANE INJECTABLE GEL
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
Q-Med AB
seminariegatan 21
uppsala SE-75-752-
PMA NumberP040024
Supplement NumberS006
Date Received03/28/2006
Decision Date05/02/2007
Product Code
LMH[ Registered Establishments with 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 Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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