IPULSE CIRCULATORY SUPPORT SYSTEM

Ventricular (assist) Bypass

FDA Premarket Approval P900023 S051

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 an increased field service interval of 5000 hours for the ipulse console.

• Device: IPULSE CIRCULATORY SUPPORT SYSTEM
• Classification Name: Ventricular (assist) Bypass
• Generic Name: Ventricular (assist) Bypass
• Applicant: ABIOMED CARDIOVASCULAR, INC.
• Date Received: 2009-04-07
• Decision Date: 2009-06-05
• PMA: P900023
• Supplement: S051
• Product Code: DSQ
• Advisory Committee: Cardiovascular
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: ABIOMED CARDIOVASCULAR, INC. 22 Cherry Hill Drive danvers, MA 01923

Supplemental Filings

Supplement Number	Date	Supplement Type
P900023		Original Filing
S052	2011-10-06	Normal 180 Day Track
S051	2009-04-07	Real-time Process
S050	2008-08-19	30-day Notice
S049	2008-08-01	Normal 180 Day Track
S048	2007-04-23	Normal 180 Day Track
S047	2006-11-13	Normal 180 Day Track
S046	2006-10-26	Real-time Process
S045
S044	2006-01-05	Real-time Process
S043	2005-01-18	Real-time Process
S042	2004-12-22	Real-time Process
S041	2004-03-26	Real-time Process
S040	2004-03-16	Real-time Process
S039	2003-12-15	Special (immediate Track)
S038	2003-01-27	Normal 180 Day Track
S037	2002-07-01	Normal 180 Day Track
S036
S035	2001-02-26	Normal 180 Day Track
S034	2000-11-15	Normal 180 Day Track
S033	2000-05-10	Normal 180 Day Track
S032	2000-03-13	Special (immediate Track)
S031	1999-10-21	Normal 180 Day Track
S030	1999-10-07	Normal 180 Day Track
S029	1999-04-02	Special (immediate Track)
S028	1999-04-02	Normal 180 Day Track
S027	1998-04-02	Real-time Process
S026	1998-01-02	Real-time Process
S025	1997-11-24	Normal 180 Day Track
S024	1997-08-11	Normal 180 Day Track
S023	1997-06-19	Normal 180 Day Track
S022	1997-03-31	Normal 180 Day Track
S021	1997-03-27	Real-time Process
S020	1996-12-06	Normal 180 Day Track
S019	1996-04-30	Normal 180 Day Track
S018	1996-04-02	Special (immediate Track)
S017	1995-10-11	Special (immediate Track)
S016	1995-08-16	Normal 180 Day Track
S015	1995-04-17	Normal 180 Day Track
S014	1994-11-04	Normal 180 Day Track
S013	1994-08-31	Normal 180 Day Track
S012	1994-08-04	Normal 180 Day Track
S011	1994-06-16	Normal 180 Day Track
S010	1994-05-18	Normal 180 Day Track
S009	1994-04-28	Normal 180 Day Track
S008	1993-12-29	Normal 180 Day Track
S007	1993-09-30	Normal 180 Day Track
S006	1993-07-08	Normal 180 Day Track
S005	1993-06-30	Normal 180 Day Track
S004	1993-04-08	Normal 180 Day Track
S003
S002
S001	1993-01-06	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00813502010848	P900023	052
00813502010398	P900023	052
00813502010381	P900023	052
00813502010374	P900023	052
00813502010367	P900023	052
00813502010350	P900023	052
00813502010343	P900023	052
00813502010336	P900023	052
00813502010329	P900023	052
00813502010312	P900023	052
00813502010305	P900023	052
00813502010299	P900023	052
00813502010282	P900023	052
00813502010275	P900023	052
00813502010268	P900023	052
00813502010404	P900023	052
00813502010671	P900023	052
00813502010688	P900023	052
00813502010831	P900023	052
00813502010817	P900023	052
00813502010800	P900023	052
00813502010794	P900023	052
00813502010787	P900023	052
00813502010770	P900023	052
00813502010763	P900023	052
00813502010756	P900023	052
00813502010749	P900023	052
00813502010732	P900023	052
00813502010725	P900023	052
00813502010718	P900023	052
00813502010701	P900023	052
00813502010695	P900023	052
00813502010251	P900023	052