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.
| Device | LITHOSTAR |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | SIEMENS CORP. |
| Date Received | 1989-04-12 |
| Decision Date | 1989-08-08 |
| PMA | P870018 |
| Supplement | S002 |
| 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 |