PMA P050047S018

Device: JUVEDERM HYALURONATE GEL IMPLANTS
Applicant: Allergan
PMA number: P050047
Supplement: S018
Product code: LMH
Decision date: 2012-01-20
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: APPROVAL TO ADD ADDITIONAL TESTING ON TWO RAW MATERIALS USED IN THE MANUFACTURE OF THE DEVICE WHICH INCLUDED ADDITIONAL TESTING OF RAW MATERIALS.

Current openFDA PMA Record#

Device: JUVEDERM HYALURONATE GEL IMPLANTS
Applicant: Allergan
PMA number: P050047
Supplement: S018
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2012-01-20
Decision code: APPR
Date received: 2011-07-07
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO ADD ADDITIONAL TESTING ON TWO RAW MATERIALS USED IN THE MANUFACTURE OF THE DEVICE WHICH INCLUDED ADDITIONAL TESTING OF RAW MATERIALS.