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.
| Device | THERASONIC LITHOTRIPSY TREATMENT SYSTEM |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | FOCUS SURGERY, INC. |
| Date Received | 1991-11-19 |
| Decision Date | 1992-10-29 |
| PMA | P890066 |
| Supplement | S003 |
| 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 | FOCUS SURGERY, INC. 1565 Barber Ln. milpitas, CA 95035 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890066 | Original Filing | |
| S005 | 1994-02-15 | Normal 180 Day Track |
| S004 | 1992-03-10 | Normal 180 Day Track |
| S003 | 1991-11-19 | Normal 180 Day Track |
| S002 | ||
| S001 | 1991-10-24 | Normal 180 Day Track |