PMA P050047S046

Device: JUVEDERM HYALURONATE GEL IMPLANTS
Applicant: Allergan
PMA number: P050047
Supplement: S046
Product code: LMH
Decision date: 2015-03-26
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: EXPANSION OF THE PRINGY II MANUFACTURING FACILITY AND ASSOCIATED MINOR CHANGES TO THE UTILITIES DISTRIBUTION SYSTEM AT THE FACILITY, TO ACCOMMODATE THE ADDEDMANUFACTURING SPACE.

Current openFDA PMA Record#

Device: JUVEDERM HYALURONATE GEL IMPLANTS
Applicant: Allergan
PMA number: P050047
Supplement: S046
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2015-03-26
Decision code: OK30
Date received: 2015-02-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: EXPANSION OF THE PRINGY II MANUFACTURING FACILITY AND ASSOCIATED MINOR CHANGES TO THE UTILITIES DISTRIBUTION SYSTEM AT THE FACILITY, TO ACCOMMODATE THE ADDEDMANUFACTURING SPACE.