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 revision of the labeling regarding the risk of hypertension following renal lithotripsy (consistent with the conclusions of your final postapproval study report).
| Device | MEDSTONE STS(TM) LITHOTRIPTER |
| Classification Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | MEDSTONE INTL., INC. |
| Date Received | 1997-10-06 |
| Decision Date | 1997-10-31 |
| PMA | P870015 |
| Supplement | S027 |
| Product Code | LNS |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDSTONE INTL., INC. 100 Columbia, Suite 100 aliso Viejo, CA 92656-4114 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870015 | Original Filing | |
| S036 | 2000-07-20 | Real-time Process |
| S035 | 2000-02-15 | Real-time Process |
| S034 | 1999-11-16 | Real-time Process |
| S033 | 1999-06-14 | Real-time Process |
| S032 | ||
| S031 | 1999-03-08 | Real-time Process |
| S030 | 1998-07-17 | Normal 180 Day Track |
| S029 | 1998-03-24 | Real-time Process |
| S028 | 1998-02-27 | Real-time Process |
| S027 | 1997-10-06 | Special (immediate Track) |
| S026 | 1997-09-22 | Real-time Process |
| S025 | 1996-10-11 | Special (immediate Track) |
| S024 | 1996-04-22 | Special (immediate Track) |
| S023 | ||
| S022 | 1996-04-08 | Normal 180 Day Track |
| S021 | 1995-07-13 | Normal 180 Day Track |
| S020 | 1994-04-12 | Normal 180 Day Track |
| S019 | 1994-03-08 | Normal 180 Day Track |
| S018 | 1992-02-28 | Normal 180 Day Track |
| S017 | 1992-02-14 | Normal 180 Day Track |
| S016 | 1992-01-29 | Normal 180 Day Track |
| S015 | 1992-01-14 | Normal 180 Day Track |
| S014 | ||
| S013 | 1991-10-15 | Normal 180 Day Track |
| S012 | 1991-09-13 | Normal 180 Day Track |
| S011 | ||
| S010 | 1990-11-21 | Normal 180 Day Track |
| S009 | 1990-06-20 | Normal 180 Day Track |
| S008 | 1989-05-09 | Normal 180 Day Track |
| S007 | ||
| S006 | ||
| S005 | ||
| S004 | ||
| S003 | 1988-06-02 | Normal 180 Day Track |
| S002 | 1988-05-19 | Normal 180 Day Track |
| S001 | 1988-05-02 | Normal 180 Day Track |