PMA P900009S048
- Device
- Exogen
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S048
- Product code
- LOF
- Decision date
- 2022-01-07
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- Use an additional supplier for the plastic housing components of the Main Operating Unit of the EXOGEN® Ultrasound Bone Healing System.
Current openFDA PMA Record#
- Device
- Exogen
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S048
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2022-01-07
- Decision code
- OK30
- Date received
- 2021-12-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use an additional supplier for the plastic housing components of the Main Operating Unit of the EXOGEN® Ultrasound Bone Healing System.