PMA P900009S047
- Device
- EXOGEN Ultrasound Bone Healing System
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S047
- Product code
- LOF
- Decision date
- 2021-08-31
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- Approval for design improvements to the Printed Circuit Board Assembly (PCBA) and the transducer cable assembly.
Current openFDA PMA Record#
- Device
- EXOGEN Ultrasound Bone Healing System
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S047
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2021-08-31
- Decision code
- APPR
- Date received
- 2021-05-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design improvements to the Printed Circuit Board Assembly (PCBA) and the transducer cable assembly.