PMA P110033S048

Device: Juvederm Injectable Gel Implants (Voluma XC, Vollure XC and Volbella XC)
Applicant: Allergan
PMA number: P110033
Supplement: S048
Product code: LMH
Decision date: 2019-08-27
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Implement a new incoming warehouse for the storage of raw materials and packaging items for Juvéderm injectable gel implants in the Pringy II building.

Current openFDA PMA Record#

Device: Juvederm Injectable Gel Implants (Voluma XC, Vollure XC and Volbella XC)
Applicant: Allergan
PMA number: P110033
Supplement: S048
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2019-08-27
Decision code: OK30
Date received: 2019-07-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement a new incoming warehouse for the storage of raw materials and packaging items for Juvéderm injectable gel implants in the Pringy II building.