This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the lithotron(tm) lithotripsy system. This device is indicated for use in patients with renal and upper ureteral calculi between 4 and 20 mm in size.
| Device | HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | HEALTH TRONICS SURGICAL SERVICES, INC. |
| Date Received | 1997-05-16 |
| Decision Date | 1997-07-21 |
| Notice Date | 1997-11-14 |
| PMA | P970019 |
| Supplement | S |
| Product Code | LNS |
| Docket Number | 97M-0453 |
| Advisory Committee | Gastroenterology/Urology |
| 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 |