PMA P900009S042
- Device
- EXOGEN Ultrasound Bone Healing System
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S042
- Product code
- LOF
- Decision date
- 2017-09-11
- Classification
- Stimulator, Bone Growth, Non-invasive
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- Addition of an alternative supplier for the rechargeable battery pack.
Current openFDA PMA Record#
- Device
- EXOGEN Ultrasound Bone Healing System
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S042
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2017-09-11
- Decision code
- OK30
- Date received
- 2017-08-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternative supplier for the rechargeable battery pack.