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 amobile version of the storz modulith lithotripter, model sl20
| Device | STORZ MODULITH (TM) LITHOTRIPTER |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Date Received | 1995-07-24 |
| Decision Date | 1995-12-19 |
| PMA | P920051 |
| Supplement | S001 |
| 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 |