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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-752-28
PMA NumberP040024
Supplement NumberS026
Date Received06/27/2008
Decision Date07/15/2008
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE FOLLOWING CHANGES TO THE PRODUCT SPECIFICATIONS FOR THE PHOSPHATE BUFFER CONCENTRATE: 1) TO NARROW THE SPECIFICATION LIMIT FOR THE CONCENTRATION OF THE BUFFERING IONS IN THE PHOSPHATE BUFFER TO 23.4 ¿ 28.4 MG/ML FOR THE POTASSIUM DIHYDROGEN PHOSPHATE CONTENT AND TO 131-157 MG/ML FOR THE DISODIUM HYDROGEN PHOSPHATE CONTENT; 2) TO ADD THE BACTERIAL ENDOTOXIN TEST TO THE PHOSPHATE BUFFER CONCENTRATE SPECIFICATION; AND 3) TO ADD THE PH TEST TO THE PHOSPHATE BUFFER SPECIFICATION.
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