FDA.reportPublic FDA data

PMA P050052S125

Device
RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler
Applicant
Merz North America, Inc.
PMA number
P050052
Supplement
S125
Product code
LMH
Decision date
2020-10-15
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Adding Merz North America as an alternate facility to perform microbial analysis of water in the microbiology laboratory at manufacturing sites of COAPTITE, RADIESSE, and RADIESSE (+) Lidocaine.

Current openFDA PMA Record#

Device
RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler
Applicant
Merz North America, Inc.
PMA number
P050052
Supplement
S125
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2020-10-15
Decision code
OK30
Date received
2020-09-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Adding Merz North America as an alternate facility to perform microbial analysis of water in the microbiology laboratory at manufacturing sites of COAPTITE, RADIESSE, and RADIESSE (+) Lidocaine.