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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 INJECTABLE GEL
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
SEMINARIEGATAN 21
UPPSALA SE-75-752-
PMA NumberP040024
Supplement NumberS052
Date Received01/28/2011
Decision Date07/18/2011
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR AN EXTENSION TO THE EXPIRATION DATE OF THE LIDOCAINE HYDROCHLORIDE RAW MATERIAL FROM 12 MONTHS TO 24 MONTHS.
Approval OrderApproval Order
Post-Approval StudyShow Report Schedule and Study Progress
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