RESTYLANE® Injectable Gels
FDA premarket approval P040024/S124 · decided 2021-10-22
Approval details
- PMA number
- P040024
- Supplement
- S124
- 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
- 2021-07-28
- Decision date
- 2021-10-22
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval to change the bacterial endotoxin specification limit of the Terumo needle co-packed with RESTYLANE® Injectable Gels.
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