FDA.reportPublic FDA data

PMA P080028

Device
Storz Medical Duolith SD1 Shock Wave Therapy Device
Applicant
Storz Medical AG
PMA number
P080028
Supplement
S001
Product code
NBN
Decision date
2020-02-05
Generic name
Generator, shock-wave, for pain relief
Approval order statement
Approval for upgrading the power supply, controller, and Graphical User Interface software revision to accommodate new hardware, as well as the addition of an optional control module and ultrasound imaging unit/monitor.

Current openFDA PMA Record#

Device
Storz Medical Duolith SD1 Shock Wave Therapy Device
Applicant
Storz Medical AG
PMA number
P080028
Supplement
S001
Product code
NBN
Generic name
Generator, shock-wave, for pain relief
Decision date
2020-02-05
Decision code
APPR
Date received
2018-12-26
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for upgrading the power supply, controller, and Graphical User Interface software revision to accommodate new hardware, as well as the addition of an optional control module and ultrasound imaging unit/monitor.