PMA P110033S019
- Device
- JUVEDERM VOLUMA XC
- Applicant
- Allergan
- PMA number
- P110033
- Supplement
- S019
- Product code
- LMH
- Decision date
- 2015-09-30
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- APPROVAL FOR REVISED LABELING TO INCLUDE FDA¿S SUGGESTED VERBIAGE, VERBATIM, TO ENHANCE THE INFORMATION PROVIDED TO PATIENTS AND PHYSICIANS ABOUT THE RISKS ASSOCIATED WITH VASCULAR INJECTION.
Current openFDA PMA Record#
- Device
- JUVEDERM VOLUMA XC
- Applicant
- Allergan
- PMA number
- P110033
- Supplement
- S019
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2015-09-30
- Decision code
- APPR
- Date received
- 2015-08-31
- Supplement type
- Special (Immediate Track)
- Approval order statement
- APPROVAL FOR REVISED LABELING TO INCLUDE FDA¿S SUGGESTED VERBIAGE, VERBATIM, TO ENHANCE THE INFORMATION PROVIDED TO PATIENTS AND PHYSICIANS ABOUT THE RISKS ASSOCIATED WITH VASCULAR INJECTION.