FDA.reportPublic FDA data

PMA P050052S127

Device
RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler
Applicant
Merz North America, Inc.
PMA number
P050052
Supplement
S127
Product code
LMH
Decision date
2020-10-23
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Permission for Merz NA to inspect incoming Glycerin raw material in-house in alignment with the USP-NF Glycerin Monograph used in COAPTITE, RADIESSE, and RADIESSE (+) products.

Current openFDA PMA Record#

Device
RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler
Applicant
Merz North America, Inc.
PMA number
P050052
Supplement
S127
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2020-10-23
Decision code
OK30
Date received
2020-09-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Permission for Merz NA to inspect incoming Glycerin raw material in-house in alignment with the USP-NF Glycerin Monograph used in COAPTITE, RADIESSE, and RADIESSE (+) products.