PMA P110033S062
- Device
- Juvéderm® Volbella™ XC
- Applicant
- Allergan
- PMA number
- P110033
- Supplement
- S062
- Product code
- LMH
- Decision date
- 2021-09-10
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for labeling update in response to the Approval Condition #7 in FDA’s approval order for P110033/S053, Juvéderm® Volbella™ XC, dated May 28, 2021.
Current openFDA PMA Record#
- Device
- Juvéderm® Volbella™ XC
- Applicant
- Allergan
- PMA number
- P110033
- Supplement
- S062
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-09-10
- Decision code
- APPR
- Date received
- 2021-06-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for labeling update in response to the Approval Condition #7 in FDA’s approval order for P110033/S053, Juvéderm® Volbella™ XC, dated May 28, 2021.