PMA P050052S139

Device: RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline
Applicant: Merz North America, Inc.
PMA number: P050052
Supplement: S139
Product code: LMH
Decision date: 2022-11-29
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Reduce the frequency of air particle sampling from the current three (3) times per month to one (1) time per month in the Merz Site 125 Cleanroom.

Current openFDA PMA Record#

Device: RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline
Applicant: Merz North America, Inc.
PMA number: P050052
Supplement: S139
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2022-11-29
Decision code: OK30
Date received: 2022-11-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Reduce the frequency of air particle sampling from the current three (3) times per month to one (1) time per month in the Merz Site 125 Cleanroom.