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 modifications to the lithotron(tm) lithotripsy system's labeling to reflect the results of this final report. Based upon the information submitted, fda believes that the postapproval report demonstrates that hypertension is not a long-term risk of extracorporeal shock wave lithotripsy, and that this postapproval requirement is now considered complete.
| Device | HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | HEALTH TRONICS SURGICAL SERVICES, INC. |
| Date Received | 1998-07-23 |
| Decision Date | 1998-11-18 |
| PMA | P970019 |
| Supplement | S003 |
| Product Code | LNS |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |