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 use of a new patient table model with the lithotron(tm) lithotripsy system, with associated labeling changes.
| Device | LITHO TRON LITHOTRIPSY SYSTEM |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | HEALTH TRONICS SURGICAL SERVICES, INC. |
| Date Received | 1998-11-12 |
| Decision Date | 1998-11-17 |
| PMA | P970019 |
| Supplement | S005 |
| 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 |