FDA.reportPublic FDA data

PMA P090016S038

Device
Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler
Applicant
Merz North America, Inc.
PMA number
P090016
Supplement
S038
Product code
LMH
Decision date
2020-02-07
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Changes to the NaHA assay for Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler, including the introduction of 125 mL HDPE bottles, the use of two series of 40 samples from each series, and the use of an alternate water source for testing.

Current openFDA PMA Record#

Device
Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler
Applicant
Merz North America, Inc.
PMA number
P090016
Supplement
S038
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2020-02-07
Decision code
OK30
Date received
2020-01-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes to the NaHA assay for Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler, including the introduction of 125 mL HDPE bottles, the use of two series of 40 samples from each series, and the use of an alternate water source for testing.