PMA P050047S044
- Device
- JUVEDERM ULTRA XC INJECTABLE GEL
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S044
- Product code
- LMH
- Decision date
- 2015-09-30
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- APPROVAL FOR THE JUVÉDERM ULTRA XC. THIS DEVICE IS INDICATED FOR:1) JUVÉDERM ULTRA XC INJECTABLE GEL IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS); AND 2) JUVÉDERM ULTRA XC IS INDICATED FOR INJECTION INTO THE LIPS AND PERIORAL AREA FOR LIP AUGMENTATION IN ADULTS OVER THE AGE OF 21.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050047S044B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- JUVEDERM ULTRA XC INJECTABLE GEL
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S044
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2015-09-30
- Decision code
- APPR
- Date received
- 2015-01-27
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE JUVÉDERM ULTRA XC. THIS DEVICE IS INDICATED FOR:1) JUVÉDERM ULTRA XC INJECTABLE GEL IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS); AND 2) JUVÉDERM ULTRA XC IS INDICATED FOR INJECTION INTO THE LIPS AND PERIORAL AREA FOR LIP AUGMENTATION IN ADULTS OVER THE AGE OF 21.