Premarket Approval (PMA)

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.

• Device: RESTYLANE, RESTYLANE-L, PERLANE, PERLANE-L, RESTYLANE SILK
• Generic Name: Implant, dermal, for aesthetic use
• Applicant: Q-Med AB; Seminariegatan 21; Uppsala SE-752-28
• PMA Number: P040024
• Supplement Number: S085
• Date Received: 09/02/2015
• Decision Date: 09/25/2015
• Product Code: LMH
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
REBUILDING OF THE MEDIA SYSTEMS WITHIN THE RESTYLANE, RESTYLANE-L, PERLANE, RESTYLANE SILK, AND RESTYLANE LYFT MANUFACTURING FACILITY.