PMA P090016S049

Device: Belotero Balance (+) Lidocaine
Applicant: Merz North America, Inc.
PMA number: P090016
Supplement: S049
Product code: LMH
Decision date: 2022-10-26
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Approval to increase the tolerance range for the lidocaine hydrochloride specification from 3.00 ± 5% mg/mL (2.85-3.15 mg/mL) to 3.0 ± 10% mg/mL (2.7 - 3.3 mg/mL).

Current openFDA PMA Record#

Device: Belotero Balance (+) Lidocaine
Applicant: Merz North America, Inc.
PMA number: P090016
Supplement: S049
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2022-10-26
Decision code: APPR
Date received: 2022-07-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to increase the tolerance range for the lidocaine hydrochloride specification from 3.00 ± 5% mg/mL (2.85-3.15 mg/mL) to 3.0 ± 10% mg/mL (2.7 - 3.3 mg/mL).