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 a new model lithotripter, to be manufactured at the vaulx-en-velin (france) facility.
| Device | EDAP LT.02 SHOCK WAVE LITHOTRIPTER |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | EDAP INTERNATIONAL CORP. |
| Date Received | 1995-05-19 |
| Decision Date | 1996-12-18 |
| PMA | P880042 |
| Supplement | S002 |
| 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 | EDAP INTERNATIONAL CORP. 179 Sidney St. cambridge, MA 02139 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880042 | Original Filing | |
| S002 | 1995-05-19 | Normal 180 Day Track |
| S001 | 1994-02-14 | Normal 180 Day Track |