Restylane Lyft with Lidocaine
FDA premarket approval P040024/S099 · decided 2018-05-18
Approval details
- PMA number
- P040024
- Supplement
- S099
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Restylane Lyft with Lidocaine
- Generic name
- Implant, dermal, for aesthetic use in the hands
- Applicant
- Q-Med AB
- Date received
- 2017-08-29
- Decision date
- 2018-05-18
- Days to decision
- 262 days
- Decision code
- APPR
- Product code
- PKY
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for the Restylane Lyft with Lidocaine for expanding the indications to include injection into the subcutaneous plane in the dorsal hand to correct volume deficit in patients over the age of 21
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