PMA P050047S033

Device: JUVEDERM HYALURONATE GEL IMPLANTS
Applicant: Allergan
PMA number: P050047
Supplement: S033
Product code: LMH
Decision date: 2014-04-17
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: APPROVAL FOR A CHANGE TO THE QUALITY CONTROL TESTING METHOD USED TO CONFIRM THE CONCENTRATION OF LIDOCAINE AND LIDOCAINE DEGREDANTS IN JUVÉDERM HYALURONATE GEL IMPLANTS.

Current openFDA PMA Record#

Device: JUVEDERM HYALURONATE GEL IMPLANTS
Applicant: Allergan
PMA number: P050047
Supplement: S033
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2014-04-17
Decision code: APPR
Date received: 2013-12-04
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE TO THE QUALITY CONTROL TESTING METHOD USED TO CONFIRM THE CONCENTRATION OF LIDOCAINE AND LIDOCAINE DEGREDANTS IN JUVÉDERM HYALURONATE GEL IMPLANTS.