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 revision of the labeling regarding the risk of hypertension following renal lithotripsy (consistent with the conclusions of your final postapproval study report).
| Device | SONOLITH 3000 LITHOTRIPTER |
| Classification Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | EDAP INTERNATIONAL CORP. |
| Date Received | 1997-10-29 |
| Decision Date | 1997-11-06 |
| PMA | P880011 |
| Supplement | S009 |
| Product Code | LNS |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |