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

• Device: Storz Medical Duolith SD1 Shock Wave Therapy
• Generic Name: Generator, Shock-wave, For Pain Relief
• Applicant: STORZ MEDICAL AG
• Date Received: 2018-12-26
• Decision Date: 2020-02-05
• PMA: P080028
• Supplement: S001
• Product Code: NBN
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: STORZ MEDICAL AG lohstampfestrasse 8 tagerwilen CH-82-8274

Supplemental Filings

Supplement Number	Date	Supplement Type
P080028		Original Filing
S001	2018-12-26	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
07630039101022	P080028	000
07630039100827	P080028	000
07630039100773	P080028	000
07630039100759	P080028	000
07630039101336	P080028	001
07630039101329	P080028	001
07630039101312	P080028	001