Restylane, Perlane, Restylane-L, Restylane Lyft (formerly Perlane-L), Restylane Silk
FDA premarket approval P040024/S097 · decided 2017-08-01
Approval details
- PMA number
- P040024
- Supplement
- S097
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restylane, Perlane, Restylane-L, Restylane Lyft (formerly Perlane-L), Restylane Silk
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2017-07-03
- Decision date
- 2017-08-01
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Changes in the storage time and F0 limit for in-house prepared microbiological media used in the microbiological testing.
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