Storz Medical Duolith SD1 Shock Wave Therapy

FDA Premarket Approval P080028 S001

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.

Pre-market Approval Supplement Details

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

DeviceStorz Medical Duolith SD1 Shock Wave Therapy
Generic NameGenerator, Shock-wave, For Pain Relief
ApplicantSTORZ MEDICAL AG
Date Received2018-12-26
Decision Date2020-02-05
PMAP080028
SupplementS001
Product CodeNBN 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address STORZ MEDICAL AG lohstampfestrasse 8 tagerwilen CH-82-8274

Supplemental Filings

Supplement NumberDateSupplement Type
P080028Original Filing
S001 2018-12-26 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
07630039101022 P080028 000
07630039100827 P080028 000
07630039100773 P080028 000
07630039100759 P080028 000

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