Restylane Injectable Gels
FDA premarket approval P040024/S131 · decided 2022-07-20
Approval details
- PMA number
- P040024
- Supplement
- S131
- Supplement type
- Real-Time Process
- 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
- 2022-04-04
- Decision date
- 2022-07-20
- Days to decision
- 107 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for alternative plunger rod and finger grip to be used with the approved Beckton Dickinson syringe system.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.