- Device
- Belotero Balance Dermal Filler
- Applicant
- Merz North America, Inc.
- PMA number
- P090016
- Supplement
- S035
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-02-06
- Decision code
- APPR
- Date received
- 2019-08-23
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for qualification of an alternative supplier of needles (27G x 1/2", 30G x 1/2") and modification of associated secondary packaging components to accommodate the new needles.