PMA P090016S028

Device: Belotero Balance (+) Lidocaine
Applicant: Merz North America, Inc.
PMA number: P090016
Supplement: S028
Product code: LMH
Decision date: 2019-08-29
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Approval for use of Belotero Balance with Integral Lidocaine for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds such as nasolabial folds.

Current openFDA PMA Record#

Device: Belotero Balance (+) Lidocaine
Applicant: Merz North America, Inc.
PMA number: P090016
Supplement: S028
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2019-08-29
Decision code: APPR
Date received: 2018-04-20
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for use of Belotero Balance with Integral Lidocaine for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds such as nasolabial folds.