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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
Se-752 28
Uppsala SE-752-28
PMA NumberP020023
Supplement NumberS010
Date Received08/24/2004
Decision Date09/17/2004
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE OF LOCATION FOR A MANUFACTURING PROCESS.
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