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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.
 
DeviceRESTYLANE L AND PERLANE L INJECTABLE GEL
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
Seminariegatan 21
Uppsala SE-752-28
PMA NumberP040024
Supplement NumberS062
Date Received07/13/2012
Decision Date08/06/2012
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN EXTENSION TO THE EXPIRATION DATE OF THE RESTYLANE L AND PERLANE L INJECTABLE GELS (0.5 AND 1.0 ML) FROM 24 MONTHS TO 36 MONTHS.
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