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 | DORNIER LITHOTRIPTER MODEL MFL 5000 |
| Classification Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Generic Name | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | Dornier MedTech America, Inc. |
| Date Received | 1991-07-12 |
| Decision Date | 1991-12-20 |
| PMA | P840008 |
| Supplement | S031 |
| 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 | 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 |