DORNIER COMPACT S) AND DORNIER LITHOTRIPTER (STATIONARY & TRANSPORTABLE

Lithotriptor, Extracorporeal Shock-wave, Urological

FDA Premarket Approval P840008 S058

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 a non-ecg shock wave trigger mode for the dornier compact s and the move and shoot feature for the dornier lithotripter (stationary and transportable).

• Device: DORNIER COMPACT S) AND DORNIER LITHOTRIPTER (STATIONARY & TRANSPORTABLE
• Classification Name: Lithotriptor, Extracorporeal Shock-wave, Urological
• Generic Name: Lithotriptor, Extracorporeal Shock-wave, Urological
• Applicant: Dornier MedTech America, Inc.
• Date Received: 1996-12-09
• Decision Date: 1997-05-05
• PMA: P840008
• Supplement: S058
• Product Code: LNS
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Normal 180 Day Track
• 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