PMA P050047S023

Device: JUVEDERM HYALURONATE GEL IMPLANTS
Applicant: Allergan
PMA number: P050047
Supplement: S023
Product code: LMH
Decision date: 2012-03-20
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: APPROVAL OF TWO CHANGES: 1) ADDITION OF A WAITING PERIOD WHILE THE GEL IS SITTING IN THE MOBILE TANK AND; 2) AN ENVIRONMENTAL CHANGE IN THE SECONDARY PACKAGING ROOM OF THE PRINGY I MANUFACTURING FACILITY.

Current openFDA PMA Record#

Device: JUVEDERM HYALURONATE GEL IMPLANTS
Applicant: Allergan
PMA number: P050047
Supplement: S023
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2012-03-20
Decision code: OK30
Date received: 2012-02-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL OF TWO CHANGES: 1) ADDITION OF A WAITING PERIOD WHILE THE GEL IS SITTING IN THE MOBILE TANK AND; 2) AN ENVIRONMENTAL CHANGE IN THE SECONDARY PACKAGING ROOM OF THE PRINGY I MANUFACTURING FACILITY.