PMA P050037S110

Device: RADIESSE Injectable Implant
Applicant: Merz North America, Inc.
Product code: LMH
Decision date: 2021-08-27
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Approval for modification of the Calcium Hydroxylapatite (CaHA) particle manufacturing process to allow for an Alternate Processing Pathway (APP) to process CaHA particle byproducts.

Current openFDA PMA Record#

Device: RADIESSE Injectable Implant
Applicant: Merz North America, Inc.
PMA number: P050037
Supplement: S110
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2021-08-27
Decision code: APPR
Date received: 2020-11-20
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for modification of the Calcium Hydroxylapatite (CaHA) particle manufacturing process to allow for an Alternate Processing Pathway (APP) to process CaHA particle byproducts.