PMA P050047S073

Device: Juvéderm Ultra, Ultra XC, Ultra Plus, and Ultra Plus XC
Applicant: Allergan
PMA number: P050047
Supplement: S073
Product code: LMH
Decision date: 2019-10-15
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Implement a change in the manual cleaning procedure for equipment used in the manufacturing of Juvederm injectable gel products in the Pringy I building in France.

Current openFDA PMA Record#

Device: Juvéderm Ultra, Ultra XC, Ultra Plus, and Ultra Plus XC
Applicant: Allergan
PMA number: P050047
Supplement: S073
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2019-10-15
Decision code: OK30
Date received: 2019-09-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement a change in the manual cleaning procedure for equipment used in the manufacturing of Juvederm injectable gel products in the Pringy I building in France.