RESTYLANE, PERLANE, RESTYLANE L, PERLANE L
FDA premarket approval P040024/S074 · decided 2014-06-25
Approval details
- PMA number
- P040024
- Supplement
- S074
- Supplement type
- 30-Day Notice
- Trade name
- RESTYLANE, PERLANE, RESTYLANE L, PERLANE L
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2014-05-28
- Decision date
- 2014-06-25
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- INTRODUCTION OF A SECOND SUPPLIER FOR READY PREPARED SOLUTIONS USED IN THE MANUFACTURE OF THE RESTYLANE INJECTABLE GELS.
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