PMA P050052S119

Device
Radiesse(+) Lidocaine
Applicant
Merz North America, Inc.
PMA number
P050052
Supplement
S119
Product code
LMH
Decision date
2020-03-17
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for a modification to the Lidocaine HCl shelf life specifications

Current openFDA PMA Record#

Device
Radiesse(+) Lidocaine
Applicant
Merz North America, Inc.
PMA number
P050052
Supplement
S119
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2020-03-17
Decision code
APPR
Date received
2019-12-18
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a modification to the Lidocaine HCl shelf life specifications