USCI DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Premarket Approval P790017

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.

Pre-market Approval Supplement Details

• Device: USCI DILATATION CATHETER
• Classification Name: Catheters, Transluminal Coronary Angioplasty, Percutaneous
• Generic Name: Catheters, Transluminal Coronary Angioplasty, Percutaneous
• Applicant: MEDTRONIC IRELAND
• Date Received: 1979-06-15
• Decision Date: 1980-03-24
• Notice Date: 1980-07-18
• PMA: P790017
• Supplement: S
• Product Code: LOX
• Docket Number: 80M-0246
• Advisory Committee: Cardiovascular
• Expedited Review: No
• Combination Product: No
• Applicant Address: MEDTRONIC IRELAND parkmore Business Park West galway

Supplemental Filings

Supplement Number	Date	Supplement Type
P790017		Original Filing
S110	2010-10-01	30-day Notice
S109	2010-08-16	30-day Notice
S108	2010-06-04	30-day Notice
S107	2010-03-22	30-day Notice
S106	2010-03-16	135 Review Track For 30-day Notice
S105
S104	2009-12-24	135 Review Track For 30-day Notice
S103	2009-11-19	30-day Notice
S102	2009-11-09	Normal 180 Day Track No User Fee
S101	2009-10-13	30-day Notice
S100	2009-01-26	Normal 180 Day Track No User Fee
S099	2008-12-16	30-day Notice
S098	2008-11-05	Normal 180 Day Track No User Fee
S097	2008-05-01	Normal 180 Day Track No User Fee
S096	2008-03-31	Normal 180 Day Track
S095	2008-03-31	Normal 180 Day Track
S094	2008-03-24	135 Review Track For 30-day Notice
S093	2007-11-13	30-day Notice
S092	2007-08-01	30-day Notice
S091	2007-08-01	30-day Notice
S090
S089
S088	2007-07-30	30-day Notice
S087	2007-07-23	30-day Notice
S086	2006-12-04	135 Review Track For 30-day Notice
S085	2006-04-17	Special (immediate Track)
S084	2005-09-23	30-day Notice
S083	2004-12-10	Real-time Process
S082	2004-04-05	Real-time Process
S081	2003-12-26	Real-time Process
S080	2003-04-30	30-day Notice
S079	2003-01-16	Real-time Process
S078	2002-12-18	Normal 180 Day Track
S077	2002-04-01	Normal 180 Day Track
S076	2001-11-05	Normal 180 Day Track
S075	2001-03-29	Real-time Process
S074	2000-09-14	Real-time Process
S073	2000-08-28	Normal 180 Day Track
S072	2000-07-14	30-day Notice
S071	2000-03-01	Normal 180 Day Track
S070
S069	1998-12-01	Normal 180 Day Track
S068	1998-12-10	30-day Notice
S067	1998-03-23	Normal 180 Day Track
S066	1998-04-01	Real-time Process
S065	1998-02-12	Real-time Process
S064	1998-01-20	Real-time Process
S063	1997-07-31	Real-time Process
S062	1997-05-30	Normal 180 Day Track
S061	1997-01-27	Real-time Process
S060	1996-12-17	Normal 180 Day Track
S059	1996-02-28	Normal 180 Day Track
S058	1995-10-03	Normal 180 Day Track
S057	1995-09-20	Normal 180 Day Track
S056	1995-04-10	30-Day Supplement
S055
S054
S053
S052	1993-06-23	Normal 180 Day Track
S051
S050
S049	1992-12-23	Normal 180 Day Track
S048
S047	1992-07-22	Normal 180 Day Track
S046	1992-06-29	Normal 180 Day Track
S045	1991-04-03	Normal 180 Day Track
S044	1992-03-03	Normal 180 Day Track
S043	1992-01-13	Normal 180 Day Track
S042
S041	1991-11-19	Normal 180 Day Track
S040	1991-02-21	Normal 180 Day Track
S039	1991-01-11	Normal 180 Day Track
S038
S037
S036
S035
S034
S033
S032
S031	1989-07-18	Normal 180 Day Track
S030
S029
S028	1989-05-26	Normal 180 Day Track
S027	1989-04-21	Normal 180 Day Track
S026	1989-04-06	Normal 180 Day Track
S025	1988-11-14	Normal 180 Day Track
S024
S023
S022	1988-08-29	Normal 180 Day Track
S021	1988-03-31	Special (immediate Track)
S020	1988-03-11	Normal 180 Day Track
S019	1988-01-22	Normal 180 Day Track
S018	1987-12-22	Normal 180 Day Track
S017	1987-11-18	Normal 180 Day Track
S016	1987-10-23	Normal 180 Day Track
S015	1987-07-15	Normal 180 Day Track
S014
S013	1987-02-02	Normal 180 Day Track
S012	1986-10-03	Normal 180 Day Track
S011	1985-06-14
S010
S009	1984-01-19
S008	1983-10-12	Normal 180 Day Track
S007	1983-07-22
S006	1982-11-05
S005	1982-10-25
S004	1982-05-18
S003	1981-08-04
S002	1981-08-04
S001	1980-12-22	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00885074196992	P790017	081
00885074197401	P790017	081
00885074197395	P790017	081
00885074197388	P790017	081
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00613994901729	P790017	096
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00613994901262	P790017	096
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00643169282063	P790017	100
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00643169282100	P790017	100
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00643169282032	P790017	100
00643169281936	P790017	100
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00643169281950	P790017	100
00643169281967	P790017	100
00643169281974	P790017	100
00643169281981	P790017	100
00643169281998	P790017	100
00643169282001	P790017	100
00643169282018	P790017	100
00643169282025	P790017	100
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