PMA P090016S033
- Device
- Belotero Balance
- Applicant
- Merz North America, Inc.
- PMA number
- P090016
- Supplement
- S033
- Product code
- LMH
- Decision date
- 2019-07-31
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Change to the analytical method used for the determination of residual BDDE concentration in Belotero Balance.
Current openFDA PMA Record#
- Device
- Belotero Balance
- Applicant
- Merz North America, Inc.
- PMA number
- P090016
- Supplement
- S033
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2019-07-31
- Decision code
- OK30
- Date received
- 2019-07-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the analytical method used for the determination of residual BDDE concentration in Belotero Balance.