RESTYLANE L AND PERLANE L INJECTABLE GEL
FDA premarket approval P040024/S062 · decided 2012-08-06
Approval details
- PMA number
- P040024
- Supplement
- S062
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RESTYLANE L AND PERLANE L INJECTABLE GEL
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2012-07-13
- Decision date
- 2012-08-06
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR AN EXTENSION TO THE EXPIRATION DATE OF THE RESTYLANE L AND PERLANE L INJECTABLE GELS (0.5 AND 1.0 ML) FROM 24 MONTHS TO 36 MONTHS.
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