|
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 | S044 |
Date Received | 06/25/2019 |
Decision Date | 12/20/2019 |
Product Code |
LOF |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modified indications for use to include adjunctive use in patients with internal or external fracture fixation hardware present, patients undergoing treatment for infection at the fracture site, and patients believed to have diminished bone quality. |