RESTYLANE INJECTABLE GEL
FDA premarket approval P040024/S055 · decided 2012-04-23
Approval details
- PMA number
- P040024
- Supplement
- S055
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTYLANE INJECTABLE GEL
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2011-11-04
- Decision date
- 2012-04-23
- Days to decision
- 171 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- 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 CR
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