PMA P090016S048

Device: Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler
Applicant: Merz North America, Inc.
PMA number: P090016
Supplement: S048
Product code: LMH
Decision date: 2022-05-05
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Modify the Depyrogenation cycle for the equipment used in the manufacturing of Belotero Balance Dermal Filler and Belotero Balance with Lidocaine Dermal Filler.

Current openFDA PMA Record#

Device: Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler
Applicant: Merz North America, Inc.
PMA number: P090016
Supplement: S048
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2022-05-05
Decision code: OK30
Date received: 2022-04-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modify the Depyrogenation cycle for the equipment used in the manufacturing of Belotero Balance Dermal Filler and Belotero Balance with Lidocaine Dermal Filler.