PMA P050047S107

Device: Juvéderm Ultra XC, and Juvéderm Ultra Plus XC
Applicant: Allergan
PMA number: P050047
Supplement: S107
Product code: LMH
Decision date: 2026-08-28
Classification: General, Plastic Surgery
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Approval for an automated Manufacturing Execution System used for the creation, execution, and management of the Electronic Batch Records (EBR) on Packaging Lines 3 and 4 in Pringy, France

Current openFDA PMA Record#

Device: Juvéderm Ultra XC, and Juvéderm Ultra Plus XC
Applicant: Allergan
PMA number: P050047
Supplement: S107
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2026-08-28
Decision code: OK30
Date received: 2026-07-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an automated Manufacturing Execution System used for the creation, execution, and management of the Electronic Batch Records (EBR) on Packaging Lines 3 and 4 in Pringy, France