RESTYLANE INJECTABLE GEL
FDA premarket approval P040024/S053 · decided 2012-01-26
Approval details
- PMA number
- P040024
- Supplement
- S053
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTYLANE INJECTABLE GEL
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2011-07-07
- Decision date
- 2012-01-26
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR A RELOCATION OF THE CURRENT QUALITY CONTROL LABORATORY (QC-LAB) FOR CHEMICAL, MICROBIOLOGICAL AND RECEIVING INSPECTION ANALYSIS TO A NEW LOCATION WITH Q-MED¿S EXISTING FACILITIES.
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