DORNIER COMPACT DELTA

Lithotriptor, Extracorporeal Shock-wave, Urological

FDA Premarket Approval P840008 S065

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.

Pre-market Approval Supplement Details

Approval for changes tot he therapy head movement capabilities, alteration of the hand held control unit, modification of the x-ray range of movement, addition of an x-ray image storage feature, ecg monitor model replacement, replacement of the charging unit, a new mounting orientation for the ultrasound arm, design changes to the patient table, a new design for the phantom support accessory, software modifications, and labeling changes. The device, as modified, will be marketed under the trade name dornier compact delta lithotripter and is indicated for fragmentation of 5 to 25 millimeter kidney stones such as renal calyx stones and renal pelivc stones.

• Device: DORNIER COMPACT DELTA
• Classification Name: Lithotriptor, Extracorporeal Shock-wave, Urological
• Generic Name: Lithotriptor, Extracorporeal Shock-wave, Urological
• Applicant: Dornier MedTech America, Inc.
• Date Received: 1998-06-25
• Decision Date: 1998-07-07
• PMA: P840008
• Supplement: S065
• Product Code: LNS
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: Dornier MedTech America, Inc. 1155 Roberts Blvd. kennesaw, GA 30144

Supplemental Filings

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

NIH GUDID Devices

Device ID	PMA	Supp
04049957000714	P840008	069
04049957000578	P840008	069
04049957000561	P840008	069
04049957000554	P840008	069