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 a compact transportable (within the hospital only) configuration of the lithostar(r) shock wave system c. The device, as modified, will be marketed under the trade name lithostar(r) modularis and is indicated for use in the fragmentation of urinary tract stones, i. E. , renal calyceal stones, renal pelvic stones, and upper ureteral stones.
| Device | MODULARIS LITHO |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | SIEMENS CORP. |
| Date Received | 1998-05-01 |
| Decision Date | 1998-09-21 |
| PMA | P870018 |
| Supplement | S021 |
| 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 | SIEMENS CORP. 186 Wood Ave., South iselin, NJ 08830 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870018 | Original Filing | |
| S025 | 2000-07-10 | Real-time Process |
| S024 | 2000-04-10 | Real-time Process |
| S023 | 1999-02-12 | Normal 180 Day Track |
| S022 | 1999-01-12 | Real-time Process |
| S021 | 1998-05-01 | Normal 180 Day Track |
| S020 | ||
| S019 | 1997-12-11 | Special (immediate Track) |
| S018 | ||
| S017 | 1997-06-17 | Normal 180 Day Track |
| S016 | 1996-05-20 | Normal 180 Day Track |
| S015 | 1996-04-11 | Normal 180 Day Track |
| S014 | 1996-03-13 | Normal 180 Day Track |
| S013 | 1996-02-23 | Normal 180 Day Track |
| S012 | ||
| S011 | 1995-09-05 | Normal 180 Day Track |
| S010 | 1995-05-08 | Normal 180 Day Track |
| S009 | 1994-02-18 | Normal 180 Day Track |
| S008 | 1994-02-07 | Normal 180 Day Track |
| S007 | 1992-06-17 | Normal 180 Day Track |
| S006 | 1992-01-29 | Normal 180 Day Track |
| S005 | 1991-10-02 | Normal 180 Day Track |
| S004 | 1990-12-07 | Normal 180 Day Track |
| S003 | 1990-11-15 | Normal 180 Day Track |
| S002 | 1989-04-12 | Normal 180 Day Track |
| S001 | 1988-12-23 | Normal 180 Day Track |