PMA P050047S060
- Device
- Juvéderm Injectable Gel Implants
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S060
- Product code
- LMH
- Decision date
- 2017-05-25
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Implementation of two additional equipment to support automated visual inspection of 1 mL syringes filled to 1.0 mL product configurations.
Current openFDA PMA Record#
- Device
- Juvéderm Injectable Gel Implants
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S060
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2017-05-25
- Decision code
- OK30
- Date received
- 2017-05-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of two additional equipment to support automated visual inspection of 1 mL syringes filled to 1.0 mL product configurations.