Restylane Kysse Injectable Gel
FDA premarket approval P140029/S029 · decided 2020-12-21
Approval details
- PMA number
- P140029
- Supplement
- S029
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Restylane Kysse Injectable Gel
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2020-08-17
- Decision date
- 2020-12-21
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for a new alternative supplier for Lidocaine Hydrochloride (Lidocaine HCl) for Restylane Kysse
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