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 INJECTABLE GEL
• Generic Name: Implant, dermal, for aesthetic use
• Applicant: Q-Med AB; Seminariegatan 21; Uppsala SE-752-28
• PMA Number: P040024
• Supplement Number: S055
• Date Received: 11/04/2011
• Decision Date: 04/23/2012
• Product Code: LMH
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 135 Review Track For 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  
APPROVAL FOR THE FOLLOWING CHANGES:1) CHANGE TO LABEL CHECK CRITERIA;2) EXTENSION OF COMPRESSED AIR DISTRIBUTION IN BUILDING 9 (PHASE 2); 3) SEALING OF VESSELS AFTER CLEAN OUT OF PLACE (COP) USING STERIKING POUCH; 4) CHANGED SAMPLING PROCEDURE FOR BIOBURDEN AND BACTERIAL ENDOTOXINS TESTS; 5) NEW SILICONIZATION AND LUER LOCK ADAPTOR ASSEMBLY PROCESSES 1ML GLASS SYRINGE AT BD; 6) TIGHTENING OF ANALYTICAL ACCEPTANCE LIMITS FOR HA CONTENT AND GEL CONTENT. CHANGEINVOLVES MODIFICATION OF ACCEPTANCE CRITERIA FOR INCOMING RAW MATERIAL, FOR A CRITICAL COMPONENT;7) TIGHTENING LIMITS FOR LIDOCAINE IN PROCESS CONTROL AND CHANGING FROM A CALCULATED TO AFIXED AMOUNT OF ADDED WATER FOR INJECTION (WFI); AND8) INSTALLATION OF NEW DIFFERENTIAL PRESSURE SENSORS.