RESTYLANE Injectable Gels
FDA premarket approval P040024/S116 · decided 2019-10-08
Approval details
- PMA number
- P040024
- Supplement
- S116
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RESTYLANE Injectable Gels
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2019-07-10
- Decision date
- 2019-10-08
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for reclassification of Impurity C in Lidocaine (HCl) of RESTYLANE Injectable Gels from a Specified Unidentified Impurity to an Unspecified Unidentified Impurity.
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