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 following device modifications: 1)inclusion of an upgraded video mixer; 2) modification of the water circuit to include pressure feedback; 3) replacement of the nylon/aluminum patient table with a carbon fiber model; 4) addition of the fvp-30 x-ray image processing feature (which also included revisions ot the x-ray operator's and service manuals)
| Device | STORZ MODULITH (TM) LITHOTRIPTER |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Date Received | 1995-09-18 |
| Decision Date | 1995-12-11 |
| PMA | P920051 |
| Supplement | S002 |
| 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 |