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.
| Device | THERASONIC LITHOTRIPSY TREATMENT SYSTEM |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | FOCUS SURGERY, INC. |
| Date Received | 1989-12-07 |
| Decision Date | 1991-12-20 |
| PMA | P890066 |
| Supplement | S |
| Product Code | LNS |
| Advisory Committee | Gastroenterology/Urology |
| 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 |