PMA P110033S022
- Device
- JUVEDERM VOLBELLA XC
- Applicant
- Allergan
- PMA number
- P110033
- Supplement
- S022
- Product code
- LMH
- Decision date
- 2016-10-03
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for changes to the dialysis and homogenization steps during the JUVEDERM VOLBELLA XC manufacturing process.
Current openFDA PMA Record#
- Device
- JUVEDERM VOLBELLA XC
- Applicant
- Allergan
- PMA number
- P110033
- Supplement
- S022
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2016-10-03
- Decision code
- APPR
- Date received
- 2016-06-09
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for changes to the dialysis and homogenization steps during the JUVEDERM VOLBELLA XC manufacturing process.