FDA.reportPublic FDA data

PMA P900009S044

Device
Exogen Ultrasound Bone Healing System
Applicant
Bioventus, LLC
PMA number
P900009
Supplement
S044
Product code
LOF
Decision date
2019-12-20
Generic name
Stimulator, bone growth, non-invasive
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.

Current openFDA PMA Record#

Device
Exogen Ultrasound Bone Healing System
Applicant
Bioventus, LLC
PMA number
P900009
Supplement
S044
Product code
LOF
Generic name
Stimulator, bone growth, non-invasive
Decision date
2019-12-20
Decision code
APPR
Date received
2019-06-25
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
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.