PMA P900009S032

Device
EXOGEN 4000+
Applicant
Bioventus, LLC
PMA number
P900009
Supplement
S032
Product code
LPQ
Decision date
2010-03-26
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
COMPONENT MANUFACTURER SITE CHANGE.

Current openFDA PMA Record#

Device
EXOGEN 4000+
Applicant
Bioventus, LLC
PMA number
P900009
Supplement
S032
Product code
LPQ
Generic name
Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Decision date
2010-03-26
Decision code
OK30
Date received
2010-02-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
COMPONENT MANUFACTURER SITE CHANGE.