RESTYLANE INJECTABLE GEL
FDA premarket approval P040024/S016 · decided 2008-06-13
Approval details
- PMA number
- P040024
- Supplement
- S016
- 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
- 2007-10-31
- Decision date
- 2008-06-13
- Days to decision
- 226 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR NEW PROCESSING VESSELS AND FOR CHANGES IN THE CLEANING PROCESS FOR THOSE VESSELS.
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