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 the oec series 9600 mobile imaging unit and a portable collision protector to be used with a transportable version of your slx lithotripter. The device, as modified, will be marketed under the trade name transportable modulith(r) slx lithotripter and is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
| Device | STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION) |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Date Received | 1997-03-26 |
| Decision Date | 1997-03-27 |
| PMA | P920051 |
| Supplement | S006 |
| Product Code | LNS |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Real-time Process |
| 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 |