Storz Medical Duolith SD1 Shock Wave Therapy Device
FDA premarket approval P080028/S001 · decided 2020-02-05
Approval details
- PMA number
- P080028
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Storz Medical Duolith SD1 Shock Wave Therapy Device
- Generic name
- Generator, shock-wave, for pain relief
- Applicant
- Storz Medical AG
- Date received
- 2018-12-26
- Decision date
- 2020-02-05
- Days to decision
- 406 days
- Decision code
- APPR
- Product code
- NBN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Tagerwilen
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Storz Medical MAGNETOLITH Muscle Stimulator (K203710) | Storz Medical AG | 2021-05-03 |
| Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece (K202112) | Storz Medical AG | 2021-02-21 |
| D-Actor 200 Vibration Massage System (K173692) | Storz Medical AG | 2018-04-13 |