PERLANE INJECTABLE GEL
FDA premarket approval P040024/S006 · decided 2007-05-02
Approval details
- PMA number
- P040024
- Supplement
- S006
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PERLANE INJECTABLE GEL
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2006-03-28
- Decision date
- 2007-05-02
- Days to decision
- 400 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR THE PERLANE INJECTABLE GEL. THE DEVICE IS INDICATED FOR IMPLANTATION INTO THE DEEP DERMIS TO SUPERFICIAL SUBCUTIS FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL FOLDS AND WRINKLES, SUCH AS NASOLABIAL FOLDS.
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