PMA P090016S046
- Device
- Belotero Balance + Lidocaine
- Applicant
- Merz North America, Inc.
- PMA number
- P090016
- Supplement
- S046
- Product code
- LMH
- Decision date
- 2021-10-13
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Qualification of an alternative supplier of needles and modification of associated secondary packaging components to accommodate the new needles.
Current openFDA PMA Record#
- Device
- Belotero Balance + Lidocaine
- Applicant
- Merz North America, Inc.
- PMA number
- P090016
- Supplement
- S046
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-10-13
- Decision code
- OK30
- Date received
- 2021-09-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of an alternative supplier of needles and modification of associated secondary packaging components to accommodate the new needles.