PMA P050037S098

Device: Radiesse Injectable Implant
Applicant: Merz North America, Inc.
PMA number: P050037
Supplement: S098
Product code: LMH
Decision date: 2019-11-06
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Approval for modifications to the manufacturing equipment for Coaptite Injectable Implant, Radiesse Injectable Implant, and Radiesse (+) Lidocaine Dermal Filler.

Current openFDA PMA Record#

Device: Radiesse Injectable Implant
Applicant: Merz North America, Inc.
PMA number: P050037
Supplement: S098
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2019-11-06
Decision code: APPR
Date received: 2019-05-16
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for modifications to the manufacturing equipment for Coaptite Injectable Implant, Radiesse Injectable Implant, and Radiesse (+) Lidocaine Dermal Filler.