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 addition of an ultrasonic stone location accessory. The device is indicated for preliminary localization of a target stone prior to extracorporeal shock wave lithotripsy with the lithotron(tm) lithotripsy system. The indications for use have not changed.
| Device | LITHOTRON ULS |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | HEALTH TRONICS SURGICAL SERVICES, INC. |
| Date Received | 1999-07-06 |
| Decision Date | 1999-12-17 |
| PMA | P970019 |
| Supplement | S006 |
| Product Code | LNS |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| 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 |