SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Premarket Approval P910001 S007

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: SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
• Classification Name: Device, Angioplasty, Laser, Coronary
• Generic Name: Device, Angioplasty, Laser, Coronary
• Applicant: SPECTRANETICS CORP.
• Date Received: 1994-05-16
• Decision Date: 1994-11-15
• PMA: P910001
• Supplement: S007
• Product Code: LPC
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: SPECTRANETICS CORP. 9965 Federal Drive colorado Springs, CO 80921

Supplemental Filings

Supplement Number	Date	Supplement Type
P910001		Original Filing
S117	2022-09-23	30-day Notice
S116	2022-06-17	Real-time Process
S115	2022-02-23	Real-time Process
S114	2022-02-14	Special (immediate Track)
S113	2021-03-03	Real-time Process
S112
S111	2020-10-19	Real-time Process
S110	2019-09-27	30-day Notice
S109	2018-12-26	135 Review Track For 30-day Notice
S108	2018-10-22	30-day Notice
S107	2018-09-24	30-day Notice
S106	2018-08-30	30-day Notice
S105	2018-07-16	30-day Notice
S104	2018-04-09	30-day Notice
S103	2018-02-28	30-day Notice
S102	2017-11-28	30-day Notice
S101
S100
S099	2017-08-22	30-day Notice
S098	2017-08-04	30-day Notice
S097	2017-08-03	Real-time Process
S096	2017-07-27	30-day Notice
S095	2017-07-24	Special (immediate Track)
S094	2017-06-30	Special (immediate Track)
S093	2017-05-22	30-day Notice
S092	2017-04-07	Special (immediate Track)
S091	2017-03-09	Real-time Process
S090	2016-12-08	30-day Notice
S089	2016-11-16	Real-time Process
S088	2016-10-04	30-day Notice
S087	2016-06-08	Special (immediate Track)
S086	2016-05-25	30-day Notice
S085	2016-03-14	Special (immediate Track)
S084	2016-03-08	30-day Notice
S083	2016-01-13	30-day Notice
S082	2015-11-25	30-day Notice
S081	2015-11-09	30-day Notice
S080	2015-09-01	30-day Notice
S079	2015-08-28	Normal 180 Day Track
S078	2015-07-22	Real-time Process
S077	2015-01-12	30-day Notice
S076	2014-12-08	30-day Notice
S075	2014-12-08	30-day Notice
S074	2014-11-18	30-day Notice
S073	2014-08-11	30-day Notice
S072	2014-07-14	Real-time Process
S071	2014-04-15	Real-time Process
S070	2014-03-19	30-day Notice
S069	2013-12-17	30-day Notice
S068
S067	2013-09-03	30-day Notice
S066	2013-07-22	30-day Notice
S065	2013-04-01	Normal 180 Day Track
S064	2013-01-30	30-day Notice
S063	2012-12-11	30-day Notice
S062	2012-11-27	30-day Notice
S061	2012-08-01	30-day Notice
S060	2012-07-02	30-day Notice
S059	2012-07-02	Normal 180 Day Track
S058	2012-06-25	30-day Notice
S057	2012-06-06	30-day Notice
S056	2012-05-08	Real-time Process
S055	2012-05-01	30-day Notice
S054	2012-04-02	30-day Notice
S053	2012-01-27	30-day Notice
S052	2011-12-02	30-day Notice
S051	2011-11-30	135 Review Track For 30-day Notice
S050	2011-10-07	Real-time Process
S049	2011-08-26	Real-time Process
S048	2011-05-10	30-day Notice
S047	2011-05-09	Normal 180 Day Track No User Fee
S046
S045	2011-02-04	135 Review Track For 30-day Notice
S044	2011-02-01	30-day Notice
S043	2011-01-06	30-day Notice
S042	2011-01-03	135 Review Track For 30-day Notice
S041	2010-12-01	30-day Notice
S040	2010-11-22	Normal 180 Day Track No User Fee
S039
S038	2010-10-12	30-day Notice
S037	2010-09-15	30-day Notice
S036
S035
S034	2010-02-18	Normal 180 Day Track No User Fee
S033	2009-09-11	Normal 180 Day Track
S032	2009-06-02	Real-time Process
S031	2009-05-05	30-day Notice
S030
S029
S028	2008-11-05	30-day Notice
S027	2008-10-30	135 Review Track For 30-day Notice
S026	2006-11-16	Normal 180 Day Track
S025	2006-04-14	Real-time Process
S024	2003-02-10	Normal 180 Day Track
S023	2003-01-31	Normal 180 Day Track No User Fee
S022
S021	2002-09-05	Normal 180 Day Track
S020	2001-03-30	Normal 180 Day Track
S019	2000-12-21	Normal 180 Day Track
S018	2000-02-09	Normal 180 Day Track
S017	1999-09-28	135 Review Track For 30-day Notice
S016	1999-06-14	Normal 180 Day Track
S015	1999-03-08	Normal 180 Day Track
S014	1998-08-25	Normal 180 Day Track
S013	1998-03-17	Normal 180 Day Track
S012	1996-11-27	Normal 180 Day Track
S011
S010	1994-09-26	Normal 180 Day Track
S009	1994-09-12	Normal 180 Day Track
S008	1994-05-24	Normal 180 Day Track
S007	1994-05-16	Normal 180 Day Track
S006	1993-07-07	Normal 180 Day Track
S005	1993-06-17	Normal 180 Day Track
S004
S003
S002	1992-09-14	Normal 180 Day Track
S001	1992-06-08	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
M204117205AA0	P910001	000
00813132025427	P910001	000
M204120008AA0	P910001	012
00813132025410	P910001	012
00813132025441	P910001	014
00813132025434	P910001	014
M204114009AA0	P910001	014
00813132025403	P910001	014
M204120009AA0	P910001	014
M204117016AA0	P910001	014
M204110001AA0	P910001	015
M204110002AA0	P910001	015
00813132025489	P910001	015
M204110003AA0	P910001	018
00813132025465	P910001	018
00813132025458	P910001	019
M204110004AA0	P910001	019
00813132025472	P910001	019
00813132029937	P910001	033
00813132027452	P910001	112