PMA P110033S046

Device: Juvederm Injectable Gel Implants
Applicant: Allergan
PMA number: P110033
Supplement: S046
Product code: LMH
Decision date: 2019-06-26
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Approval for inclusion of an additional inspection step to the current manual inspection method during the manufacturing process for the Juvederm Injectable Gel Implants.

Current openFDA PMA Record#

Device: Juvederm Injectable Gel Implants
Applicant: Allergan
PMA number: P110033
Supplement: S046
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2019-06-26
Decision code: APPR
Date received: 2019-05-28
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for inclusion of an additional inspection step to the current manual inspection method during the manufacturing process for the Juvederm Injectable Gel Implants.