LITHOTRON ULTRA LITHOSTRIPSY SYSTEM
FDA premarket approval P970019/S004 · decided 1998-09-11
Approval details
- PMA number
- P970019
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LITHOTRON ULTRA LITHOSTRIPSY SYSTEM
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Healthtronics Surgical Services, Inc.
- Date received
- 1998-08-27
- Decision date
- 1998-09-11
- Days to decision
- 15 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marietta, GA
- Statement
- Approval for the following modifications to the LithoTron(TM) Lithotripsy System: 1) replacement of the transportable C-arm fluoroscopy system with an upgraded, stationary x-ray imaging system, 2) replacement of the existing patient table with one that offers Trendelenburg positioning, and 3) the addition of motorized movement of the shock wave therapy head. The device is indicated for use in patients with renal and upper ureteral calculi between 4mm and 20mm in size.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| TWINTRODE ELC 134 ELECTRODE (K012785) | Healthtronics Surgical Services, Inc. | 2001-11-16 |
| HEALTHTRONIC OMEGA TRAC (K881902) | Healthtronics Surgical Services, Inc. | 1988-06-22 |