PMA P050047S051

Device: JUVEDERM HYALURONATE GEL IMPLANTS
Applicant: Allergan
PMA number: P050047
Supplement: S051
Product code: LMH
Decision date: 2015-10-23
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: IMPLEMENTATION OF AN AUTOMATED VISUAL INSPECTION PROCESS AND ACCOMPANYING IN-PROCESS CONTROL FOR INSPECTING THE 0.8 ML SYRINGE CONFIGURATION OF JUVEDERM HYALURONATE GEL IMPLANTS.

Current openFDA PMA Record#

Device: JUVEDERM HYALURONATE GEL IMPLANTS
Applicant: Allergan
PMA number: P050047
Supplement: S051
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2015-10-23
Decision code: OK30
Date received: 2015-09-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: IMPLEMENTATION OF AN AUTOMATED VISUAL INSPECTION PROCESS AND ACCOMPANYING IN-PROCESS CONTROL FOR INSPECTING THE 0.8 ML SYRINGE CONFIGURATION OF JUVEDERM HYALURONATE GEL IMPLANTS.