PMA P050052

Device: RADIESSE® Injectable Implant, RADIESSE® Hands
Applicant: Merz North America, Inc.
PMA number: P050052
Supplement: S142
Product code: LMH
Decision date: 2026-05-14
Generic name: Implant, dermal, for aesthetic use
Approval order statement: installation and qualification of a new microscope in the Quality Laboratory for post-sterilization particle size testing of Radiesse® and Coaptite®

Current openFDA PMA Record#

Device: RADIESSE® Injectable Implant, RADIESSE® Hands
Applicant: Merz North America, Inc.
PMA number: P050052
Supplement: S178
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2026-05-14
Decision code: OK30
Date received: 2026-04-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: installation and qualification of a new microscope in the Quality Laboratory for post-sterilization particle size testing of Radiesse® and Coaptite®