PMA P110033S025
- Device
- JUVEDERM VOLUMA XC AND JUVEDERM VOLBELLA XC
- Applicant
- Allergan
- PMA number
- P110033
- Supplement
- S025
- Product code
- LMH
- Decision date
- 2017-01-17
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Change to the cleaning procedure of mixing and transfer vessels used during the manufacturing of Juvederm injectable gel products.
Current openFDA PMA Record#
- Device
- JUVEDERM VOLUMA XC AND JUVEDERM VOLBELLA XC
- Applicant
- Allergan
- PMA number
- P110033
- Supplement
- S025
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2017-01-17
- Decision code
- OK30
- Date received
- 2016-12-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the cleaning procedure of mixing and transfer vessels used during the manufacturing of Juvederm injectable gel products.