USCI GRUNTZIG DILACA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Premarket Approval P790017 S021

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

• Device: USCI GRUNTZIG DILACA CATHETER
• Classification Name: Catheters, Transluminal Coronary Angioplasty, Percutaneous
• Generic Name: Catheters, Transluminal Coronary Angioplasty, Percutaneous
• Applicant: MEDTRONIC IRELAND
• Date Received: 1988-03-31
• Decision Date: 1988-06-09
• PMA: P790017
• Supplement: S021
• Product Code: LOX
• Advisory Committee: Cardiovascular
• Supplement Type: Special (immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• 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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00643169281981	P790017	100
00643169281998	P790017	100
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00643169282018	P790017	100
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