PMA P090016S043
- Device
- Belotero Balance
- Applicant
- Merz North America, Inc.
- PMA number
- P090016
- Supplement
- S043
- Product code
- LMH
- Decision date
- 2020-10-29
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Addition of a camera system to the carton packaging line and the change to the tamper evident seal of the carton packaging.
Current openFDA PMA Record#
- Device
- Belotero Balance
- Applicant
- Merz North America, Inc.
- PMA number
- P090016
- Supplement
- S043
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-10-29
- Decision code
- OK30
- Date received
- 2020-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a camera system to the carton packaging line and the change to the tamper evident seal of the carton packaging.