PMA P900009S046
- Device
- EXOGEN Ultrasound Bone Healing System
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S046
- Product code
- LOF
- Decision date
- 2021-04-14
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- Use an additional supplier for the ultrasound gel provided with the EXOGEN Ultrasound Bone Healing System.
Current openFDA PMA Record#
- Device
- EXOGEN Ultrasound Bone Healing System
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S046
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2021-04-14
- Decision code
- OK30
- Date received
- 2021-03-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use an additional supplier for the ultrasound gel provided with the EXOGEN Ultrasound Bone Healing System.