JUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC
FDA premarket approval P050047/S005 · decided 2010-01-07
Approval details
- PMA number
- P050047
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- JUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Allergan
- Date received
- 2008-08-18
- Decision date
- 2010-01-07
- Days to decision
- 507 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE ADDITION OF 0.3% LIDOCAINE INTO JUVEDERM ULTRA AND JUVEDERM ULTRA PLUS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME JUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC AND IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).
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