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.
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.
| Device | LITHOTRON ULTRA LITHOSTRIPSY SYSTEM |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | HEALTH TRONICS SURGICAL SERVICES, INC. |
| Date Received | 1998-08-27 |
| Decision Date | 1998-09-11 |
| PMA | P970019 |
| Supplement | S004 |
| Product Code | LNS |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HEALTH TRONICS SURGICAL SERVICES, INC. 425 Franklin Rd., Suite 545 marietta, GA 30067 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970019 | Original Filing | |
| S006 | 1999-07-06 | Normal 180 Day Track |
| S005 | 1998-11-12 | Real-time Process |
| S004 | 1998-08-27 | Real-time Process |
| S003 | 1998-07-23 | Normal 180 Day Track |
| S002 | 1998-05-18 | Normal 180 Day Track |
| S001 | 1997-11-05 | Real-time Process |