RESTYLANE
FDA premarket approval P020023/S009 · decided 2004-08-06
Approval details
- PMA number
- P020023
- Supplement
- S009
- Supplement type
- Real-Time Process
- 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
- 2004-07-09
- Decision date
- 2004-08-06
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR INCREASING THE EXPIRATION DATING FOR RESTYLANE FROM 24 MONTHS TO 36 MONTHS.
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