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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DeviceStorz Medical Duolith SD1 Shock Wave Therapy Device
Generic Namegenerator, shock-wave, for pain relief
lohstampfestrasse 8
tagerwilen CH-82-8274
PMA NumberP080028
Supplement NumberS001
Date Received12/26/2018
Decision Date02/05/2020
Product Code NBN 
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
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.