PMA P110033S035
- Device
- Juvederm Volbella XC
- Applicant
- Allergan
- PMA number
- P110033
- Supplement
- S035
- Product code
- LMH
- Decision date
- 2017-12-14
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Implementation of an automated visual inspection process for Juvederm Volbella XC in the 0.55 mL fill volume configuration.
Current openFDA PMA Record#
- Device
- Juvederm Volbella XC
- Applicant
- Allergan
- PMA number
- P110033
- Supplement
- S035
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2017-12-14
- Decision code
- OK30
- Date received
- 2017-11-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an automated visual inspection process for Juvederm Volbella XC in the 0.55 mL fill volume configuration.