PMA P050047S076
- Device
- Juvéderm Injectable Gel Implants
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S076
- Product code
- LMH
- Decision date
- 2020-05-28
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for reducing the bacterial endotoxin specification to enhance the safety of the device.
Current openFDA PMA Record#
- Device
- Juvéderm Injectable Gel Implants
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S076
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-05-28
- Decision code
- APPR
- Date received
- 2020-05-01
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for reducing the bacterial endotoxin specification to enhance the safety of the device.