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 of a mobile version of the modulith(r) slx lithotripter. The device, as modified, will be marketed under the trade name the storz modulith(r) slx mobile lithotripter, and is indicated for use in the noninvasive gragmentation of urinary calculi in the kidney and upper ureter.
| Device | STORZ MODULITH LITHOTRIPTER, MODEL SLX FOR FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI (MOBILE VERSION) |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Date Received | 1996-08-30 |
| Decision Date | 1997-01-10 |
| PMA | P920051 |
| Supplement | S004 |
| 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 | 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 |