PMA P050037S154

Device: RADIESSE® Injectable Implant
Applicant: Merz North America, Inc.
PMA number: P050037
Supplement: S154
Product code: LMH
Decision date: 2026-06-26
Classification: General, Plastic Surgery
Generic name: Implant, dermal, for aesthetic use
Approval order statement: modification of the Dynamic Crossflow Filtration (DCF) System for use in calcium hydroxylapatite (CaHA) particle manufacturing for the Radiesse, Radiesse (+), and Coaptite product lines.

Current openFDA PMA Record#

Device: RADIESSE® Injectable Implant
Applicant: Merz North America, Inc.
PMA number: P050037
Supplement: S154
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2026-06-26
Decision code: OK30
Date received: 2026-05-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: modification of the Dynamic Crossflow Filtration (DCF) System for use in calcium hydroxylapatite (CaHA) particle manufacturing for the Radiesse, Radiesse (+), and Coaptite product lines.