PMA P900009S039

Device
EXOGEN ULTRASOUND BONE HEALING SYSTEM
Applicant
Bioventus, LLC
PMA number
P900009
Supplement
S039
Product code
LPQ
Decision date
2015-04-22
Classification
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Generic name
Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Approval order statement
ALTERNATE SUPPLIER.

Current openFDA PMA Record#

Device
EXOGEN ULTRASOUND BONE HEALING SYSTEM
Applicant
Bioventus, LLC
PMA number
P900009
Supplement
S039
Product code
LPQ
Generic name
Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Decision date
2015-04-22
Decision code
OK30
Date received
2015-03-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE SUPPLIER.