Restylane Lyft with Lidocaine Cannula Injection
FDA premarket approval P040024/S101 · decided 2018-11-02
Approval details
- PMA number
- P040024
- Supplement
- S101
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Restylane Lyft with Lidocaine Cannula Injection
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2018-04-20
- Decision date
- 2018-11-02
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for the use of a small bore, blunt tip cannula with Restylane Lyft with Lidocaine for cheek augmentation and the correction of age related midface contour deficiencies in patients over the age of 21.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.