RESTYLANE, RESTYLANE-L, RESTYLANE LYFT, RESTYLANE SILK, PERLANE
FDA premarket approval P040024/S087 · decided 2015-11-06
Approval details
- PMA number
- P040024
- Supplement
- S087
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTYLANE, RESTYLANE-L, RESTYLANE LYFT, RESTYLANE SILK, PERLANE
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2015-10-15
- Decision date
- 2015-11-06
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- A REBUILD OF THE MANUFACTURING LINE L3 CLEAN ROOMS AT Q-MED'S FACILITY 2 IN UPPSALA, SWEDEN.
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