PMA P050052S121

Device
RADIESSE Injectable Implant, RADIESSE Hands AND Radiesse (+) Lidocaine Demral Filler
Applicant
Merz North America, Inc.
PMA number
P050052
Supplement
S121
Product code
LMH
Decision date
2020-04-15
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Removal of obsolete equipment.

Current openFDA PMA Record#

Device
RADIESSE Injectable Implant, RADIESSE Hands AND Radiesse (+) Lidocaine Demral Filler
Applicant
Merz North America, Inc.
PMA number
P050052
Supplement
S121
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2020-04-15
Decision code
OK30
Date received
2020-04-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Removal of obsolete equipment.