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 | TECHNOMED INTERNATIONAL SONOLITH 3000 |
| Classification Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | EDAP INTERNATIONAL CORP. |
| Date Received | 1994-03-08 |
| Decision Date | 1994-04-18 |
| PMA | P880011 |
| Supplement | S008 |
| Product Code | LNS |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EDAP INTERNATIONAL CORP. two Burlington Woods burlington, MA 01803 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880011 | Original Filing | |
| S009 | 1997-10-29 | Special (immediate Track) |
| S008 | 1994-03-08 | Normal 180 Day Track |
| S007 | 1991-11-01 | Normal 180 Day Track |
| S006 | ||
| S005 | ||
| S004 | 1990-09-24 | Normal 180 Day Track |
| S003 | 1990-09-11 | Normal 180 Day Track |
| S002 | 1989-04-28 | Normal 180 Day Track |
| S001 | 1989-04-05 | Normal 180 Day Track |