PMA P110033S008
- Device
- JUVEDERM VOLUMA XC
- Applicant
- Allergan
- PMA number
- P110033
- Supplement
- S008
- Product code
- LMH
- Decision date
- 2014-06-10
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- CHANGE TO THE UNIT OF MEASUREMENT FOR GEL TO BE MIXED AND A CHANGE TO THE IN PROCESS CONCENTRATION OF THE LIDOCAINE SOLUTION MIXED INTO THE GEL DURING HOMOGENIZATION.
Current openFDA PMA Record#
- Device
- JUVEDERM VOLUMA XC
- Applicant
- Allergan
- PMA number
- P110033
- Supplement
- S008
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2014-06-10
- Decision code
- OK30
- Date received
- 2014-05-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE UNIT OF MEASUREMENT FOR GEL TO BE MIXED AND A CHANGE TO THE IN PROCESS CONCENTRATION OF THE LIDOCAINE SOLUTION MIXED INTO THE GEL DURING HOMOGENIZATION.