RESTYLANE INJECTABLE GEL
FDA premarket approval P020023 · decided 2003-12-12
Approval details
- PMA number
- P020023
- Trade name
- RESTYLANE INJECTABLE GEL
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2002-06-19
- Decision date
- 2003-12-12
- Days to decision
- 541 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR THE RESTYLANE INJECTABLE GEL. THE DEVICE IS INDICATED FOR MID-TO-DEEP DERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS.
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