PMA P050047S039
- Device
- JUVEDERM ULTRA, JUVEDERM ULTRA PLUS, JUVEDERM ULTRA XC, JUVEDERM ULTRA PLUS XC
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S039
- Product code
- LMH
- Decision date
- 2014-07-09
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- REMOVAL OF AN IN-PROCESS CONTROL TEST USED DURING THE MANUFACTURE OF JUVÉDERM HYALURONATE GEL IMPLANTS.
Current openFDA PMA Record#
- Device
- JUVEDERM ULTRA, JUVEDERM ULTRA PLUS, JUVEDERM ULTRA XC, JUVEDERM ULTRA PLUS XC
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S039
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2014-07-09
- Decision code
- OK30
- Date received
- 2014-06-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REMOVAL OF AN IN-PROCESS CONTROL TEST USED DURING THE MANUFACTURE OF JUVÉDERM HYALURONATE GEL IMPLANTS.