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 modifying your user's manual. The device, as modified, will be marketed under the trade name lithostar
| Device | LITHOSTAR |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | SIEMENS CORP. |
| Date Received | 1996-05-20 |
| Decision Date | 1996-06-21 |
| PMA | P870018 |
| Supplement | S016 |
| Product Code | LNS |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |