Restylane Injectable Gels
FDA premarket approval P040024/S117 · decided 2020-10-01
Approval details
- PMA number
- P040024
- Supplement
- S117
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Restylane Injectable Gels
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2019-09-27
- Decision date
- 2020-10-01
- Days to decision
- 370 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for the addition of an alternate qualified supplier for Lidocaine HCl.
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