ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM

Ventricular (assist) Bypass

FDA Premarket Approval P900023 S042

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 change to only the ab5000 circulatory support system that will allow the user an alternate means of reducing blood flow during weaning by adjusting the level of vacuum applied to the ab5000 blood pump.

DeviceABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM
Classification NameVentricular (assist) Bypass
Generic NameVentricular (assist) Bypass
ApplicantABIOMED CARDIOVASCULAR, INC.
Date Received2004-12-22
Decision Date2005-03-23
PMAP900023
SupplementS042
Product CodeDSQ
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ABIOMED CARDIOVASCULAR, INC. 22 Cherry Hill Drive danvers, MA 01923

Supplemental Filings

Supplement NumberDateSupplement Type
P900023Original 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 IDPMASupp
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
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