Approval for the genestone 190 lithotripter. This device is indicated for use in the non-invasive fragmentation of kidney (renal pelvic and renal calyceal) and upper ureteral stones between 5 and 20mm in size.
| Device | GENESTONE 190 LITHOTRIPTER |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | BMT, INC. |
| Date Received | 1997-12-23 |
| Decision Date | 1998-06-24 |
| Notice Date | 1998-10-07 |
| PMA | P970062 |
| Supplement | S |
| Product Code | LNS |
| Docket Number | 98M-0507 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BMT, INC. 660 Main St. South suite 7 woodbury, CT 06798 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970062 | Original Filing |