PMA P110033S007

Device: JUVEDERM VOLUMA XC
Applicant: Allergan
PMA number: P110033
Supplement: S007
Product code: LMH
Decision date: 2014-09-11
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: APPROVAL FOR MOVING BIOBURDEN TESTING, CONDUCTED AS PART OF ROUTINE QUALITY CONTROL PROCEDURES FOR JUVÉDERM HYALURONATE GEL IMPLANTS AND JUVÉDERM VOLUMA XC, FROM A CONTRACT LABORATORY TO IN-HOUSE.

Current openFDA PMA Record#

Device: JUVEDERM VOLUMA XC
Applicant: Allergan
PMA number: P110033
Supplement: S007
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2014-09-11
Decision code: APPR
Date received: 2014-05-01
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR MOVING BIOBURDEN TESTING, CONDUCTED AS PART OF ROUTINE QUALITY CONTROL PROCEDURES FOR JUVÉDERM HYALURONATE GEL IMPLANTS AND JUVÉDERM VOLUMA XC, FROM A CONTRACT LABORATORY TO IN-HOUSE.