RESTYLANE
FDA premarket approval P040024/S089 · decided 2015-11-23
Approval details
- PMA number
- P040024
- Supplement
- S089
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RESTYLANE
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2015-10-29
- Decision date
- 2015-11-23
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR ADDITIONAL LANGUAGE IN PATIENT AND PROVIDER LABELING REGARDING THE RISK OF INTRAVASCULAR INJECTION OF SOFT TISSUE FILLERS.
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