|
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 | S047 |
Date Received | 05/25/2021 |
Decision Date | 08/31/2021 |
Product Code |
LOF |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for design improvements to the Printed Circuit Board Assembly (PCBA) and the transducer cable assembly. |