PMA P050047S024

Device: JUVEDERM HYALURONATE GEL IMPLANTS
Applicant: Allergan
PMA number: P050047
Supplement: S024
Product code: LMH
Decision date: 2012-04-16
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: REVIEW TO INCREASE THE NUMBER OF SYRINGES DRIED IN THE DRYING OVENS AND HARMONIZE THE NUMBER OF SYRINGES DRIED PER DRYING CYCLE WITH THE NUMBER OF SYRINGES STERILIZED PER STERILIZATION CYCLE.

Current openFDA PMA Record#

Device: JUVEDERM HYALURONATE GEL IMPLANTS
Applicant: Allergan
PMA number: P050047
Supplement: S024
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2012-04-16
Decision code: OK30
Date received: 2012-03-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REVIEW TO INCREASE THE NUMBER OF SYRINGES DRIED IN THE DRYING OVENS AND HARMONIZE THE NUMBER OF SYRINGES DRIED PER DRYING CYCLE WITH THE NUMBER OF SYRINGES STERILIZED PER STERILIZATION CYCLE.