|
Device | EXOGEN® Ultrasound Bone Healing System |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | BIOVENTUS LLC 4721 EMPEROR BLVD SUITE 100 DURHAM, NC 27703 |
PMA Number | P900009 |
Supplement Number | S049 |
Date Received | 07/20/2023 |
Decision Date | 12/21/2023 |
Product Code |
LOF |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an additional manufacturing site (Bioventus LLC, Cordova, Tennessee, FEI # 302669735) for the EXOGEN Ultrasound Bone Healing System. |