This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE (DLCT) |
| Classification Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | Dornier MedTech America, Inc. |
| Date Received | 1984-02-22 |
| Decision Date | 1984-12-19 |
| Notice Date | 1985-01-16 |
| PMA | P840008 |
| Supplement | S |
| Product Code | LNS |
| Docket Number | 84M-0438 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Dornier MedTech America, Inc. 1155 Roberts Blvd. kennesaw, GA 30144 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840008 | Original Filing | |
| S069 | 1999-08-20 | Real-time Process |
| S068 | 1999-02-24 | Real-time Process |
| S067 | 1999-02-02 | Normal 180 Day Track |
| S066 | 1998-07-28 | Real-time Process |
| S065 | 1998-06-25 | Real-time Process |
| S064 | 1998-05-26 | Real-time Process |
| S063 | 1998-05-18 | Special (immediate Track) |
| S062 | 1998-02-25 | Normal 180 Day Track |
| S061 | 1997-10-21 | Real-time Process |
| S060 | 1996-12-16 | Real-time Process |
| S059 | 1996-12-16 | Real-time Process |
| S058 | 1996-12-09 | Normal 180 Day Track |
| S057 | 1996-11-01 | Normal 180 Day Track |
| S056 | 1996-07-01 | Normal 180 Day Track |
| S055 | ||
| S054 | 1996-03-22 | Normal 180 Day Track |
| S053 | 1995-12-04 | Normal 180 Day Track |
| S052 | 1995-08-09 | Normal 180 Day Track |
| S051 | 1995-05-01 | Normal 180 Day Track |
| S050 | 1995-02-28 | Normal 180 Day Track |
| S049 | 1994-06-08 | Normal 180 Day Track |
| S048 | 1994-04-18 | Normal 180 Day Track |
| S047 | 1993-08-09 | Normal 180 Day Track |
| S046 | 1993-07-19 | Normal 180 Day Track |
| S045 | 1993-03-11 | Normal 180 Day Track |
| S044 | 1993-02-22 | Normal 180 Day Track |
| S043 | ||
| S042 | 1992-07-07 | Normal 180 Day Track |
| S041 | 1992-06-26 | Normal 180 Day Track |
| S040 | 1992-05-11 | Panel Track |
| S039 | 1992-05-04 | Normal 180 Day Track |
| S038 | 1992-04-09 | Normal 180 Day Track |
| S037 | 1992-02-03 | Normal 180 Day Track |
| S036 | ||
| S035 | 1991-10-08 | Normal 180 Day Track |
| S034 | 1991-09-30 | Normal 180 Day Track |
| S033 | 1991-09-11 | Normal 180 Day Track |
| S032 | 1991-08-26 | Normal 180 Day Track |
| S031 | 1991-07-12 | Normal 180 Day Track |
| S030 | 1991-06-21 | Normal 180 Day Track |
| S029 | 1991-05-24 | Normal 180 Day Track |
| S028 | 1991-03-11 | Normal 180 Day Track |
| S027 | 1991-01-09 | Normal 180 Day Track |
| S026 | 1990-05-21 | Panel Track |
| S025 | 1990-09-14 | Normal 180 Day Track |
| S024 | 1990-06-18 | Normal 180 Day Track |
| S023 | 1990-02-08 | Normal 180 Day Track |
| S022 | ||
| S021 | 1989-05-03 | Normal 180 Day Track |
| S020 | ||
| S019 | 1988-05-09 | 30-Day Supplement |
| S018 | 1987-10-05 | Normal 180 Day Track |
| S017 | ||
| S016 | 1987-09-15 | Normal 180 Day Track |
| S015 | 1987-07-10 | Normal 180 Day Track |
| S014 | 1987-06-23 | Normal 180 Day Track |
| S013 | 1987-06-12 | Normal 180 Day Track |
| S012 | 1987-05-19 | Normal 180 Day Track |
| S011 | 1987-04-13 | Normal 180 Day Track |
| S010 | 1987-03-19 | Normal 180 Day Track |
| S009 | 1986-12-12 | Normal 180 Day Track |
| S008 | 1986-09-09 | Normal 180 Day Track |
| S007 | 1986-07-03 | Normal 180 Day Track |
| S006 | 1986-06-19 | Normal 180 Day Track |
| S005 | 1986-06-10 | Special (immediate Track) |
| S004 | 1986-02-28 | Normal 180 Day Track |
| S003 | 1985-12-24 | Normal 180 Day Track |
| S002 | 1985-11-22 | Normal 180 Day Track |
| S001 | 1985-10-31 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 04049957000714 | P840008 | 069 |
| 04049957000578 | P840008 | 069 |
| 04049957000561 | P840008 | 069 |
| 04049957000554 | P840008 | 069 |