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.
Storz modulith lithotripter, model sl20 - the device is an extracorporeal shock wave lithotripter
| Device | STORZ MODULITH (TM) LITHOTRIPTER |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Date Received | 1992-11-24 |
| Decision Date | 1995-02-17 |
| Notice Date | 1995-12-15 |
| PMA | P920051 |
| Supplement | S |
| Product Code | LNS |
| Docket Number | 95m-0396 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | KARL STORZ ENDOSCOPY-AMERICA, INC. 1201 Roberts Blvd. kennesaw, GA 30144 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P920051 | Original Filing | |
| S007 | 1997-10-02 | Special (immediate Track) |
| S006 | 1997-03-26 | Real-time Process |
| S005 | 1996-10-08 | Normal 180 Day Track |
| S004 | 1996-08-30 | Normal 180 Day Track |
| S003 | 1996-04-17 | Normal 180 Day Track |
| S002 | 1995-09-18 | Normal 180 Day Track |
| S001 | 1995-07-24 | Normal 180 Day Track |