VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS

Implantable Cardioverter Defibrillator (non-crt)

FDA Premarket Approval P830060

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

Approval for the automatic implantable cardioverter defibrillator (aicd). The device is indicated for the treatment of ventricular tachycardia and ventricular fibrillation in those patients who are at high risk of sudden cardia death. Such patients are defined as (1) those who have survived at least one episode of cardiac arrest presumably due to hemodynamically unstable ventricular tachyarrhythmia not associated with acute myocardial infarction, and (2) those who, in the absence of such previous arrest, have experienced recurrent ventricular tachyarrhythmias and are inducible into sustained hypotensive ventricular tachycardia and/or fibrillation despite conventional antiarrhythmic drug therapy. The patients who meet the above criteria should have also undergone a complete cardiological evaluation that includes electrophysiological testing.

DeviceVENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS
Classification NameImplantable Cardioverter Defibrillator (non-crt)
Generic NameImplantable Cardioverter Defibrillator (non-crt)
ApplicantBOSTON SCIENTIFIC
Date Received1983-09-26
Decision Date1985-10-04
Notice Date1985-11-15
PMAP830060
SupplementS
Product CodeLWS
Docket Number85M-0504
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112
Post-Approval Study:Show Report Schedule and Study Progress

Supplemental Filings

Supplement NumberDateSupplement Type
P830060Original Filing
S088 2022-11-01 30-day Notice
S087 2021-09-30 30-day Notice
S086 2021-04-30 30-day Notice
S085 2021-03-08 30-day Notice
S084 2021-02-24 Normal 180 Day Track No User Fee
S083 2019-03-13 30-day Notice
S082 2018-03-26 30-day Notice
S081 2016-05-27 30-day Notice
S080 2014-06-30 30-day Notice
S079 2014-04-22 30-day Notice
S078 2014-03-04 Real-time Process
S077 2014-02-21 Real-time Process
S076 2013-08-29 30-day Notice
S075 2013-05-16 Real-time Process
S074 2012-11-08 30-day Notice
S073 2012-10-10 30-day Notice
S072 2012-07-26 Real-time Process
S071
S070 2012-03-26 30-day Notice
S069 2011-05-25 30-day Notice
S068 2011-04-01 30-day Notice
S067 2011-03-28 Real-time Process
S066
S065 2009-12-18 30-day Notice
S064 2009-12-16 30-day Notice
S063
S062 2009-02-24 Normal 180 Day Track
S061
S060 2006-04-13 30-day Notice
S059 2006-04-13 30-day Notice
S058 2005-05-27 Special (immediate Track)
S057 2004-12-03 30-day Notice
S056 2004-10-21 30-day Notice
S055 2004-06-14 30-day Notice
S054 2004-04-14 30-day Notice
S053 2004-01-13 30-day Notice
S052 2003-10-30 Special (immediate Track)
S051 2002-11-13 30-day Notice
S050
S049 2000-08-21 Normal 180 Day Track
S048 2000-04-27 Real-time Process
S047 2000-01-11 Real-time Process
S046 1999-12-16 Normal 180 Day Track
S045 1999-08-25 Normal 180 Day Track
S044 1998-11-20 Real-time Process
S043 1998-10-13 Real-time Process
S042 1996-10-16 Normal 180 Day Track
S041 1995-12-21 Normal 180 Day Track
S040 1995-02-10 Normal 180 Day Track
S039 1995-05-01 Normal 180 Day Track
S038 1995-04-06 Normal 180 Day Track
S037 1994-12-23 Normal 180 Day Track
S036 1994-12-14 Normal 180 Day Track
S035 1994-04-20 Normal 180 Day Track
S034 1993-10-19 Normal 180 Day Track
S033 1993-04-15 Normal 180 Day Track
S032 1992-08-26 Normal 180 Day Track
S031
S030 1992-04-29 Normal 180 Day Track
S029 1991-11-22 Normal 180 Day Track
S028 1991-11-07 Normal 180 Day Track
S027 1991-09-23 Normal 180 Day Track
S026 1991-07-05 Normal 180 Day Track
S025 1991-05-15 Normal 180 Day Track
S024 1990-11-13 Normal 180 Day Track
S023 1990-09-27 Normal 180 Day Track
S022 1990-09-26 Normal 180 Day Track
S021 1990-08-15 Normal 180 Day Track
S020 1990-07-23 Normal 180 Day Track
S019 1990-05-04 Normal 180 Day Track
S018 1990-03-07 Normal 180 Day Track
S017
S016 1990-03-01 Normal 180 Day Track
S015 1990-02-15 Normal 180 Day Track
S014 1990-02-15 Normal 180 Day Track
S013 1989-11-20 Normal 180 Day Track
S012 1989-10-31 Normal 180 Day Track
S011 1989-10-17 Normal 180 Day Track
S010 1989-10-12 Normal 180 Day Track
S009
S008 1989-06-13 Normal 180 Day Track
S007 1988-08-15 Normal 180 Day Track
S006 1988-03-08 Normal 180 Day Track
S005 1987-09-22 Normal 180 Day Track
S004 1986-09-16 Normal 180 Day Track
S003 1986-08-06 Special (immediate Track)
S002 1986-02-03
S001 1985-12-03

NIH GUDID Devices

Device IDPMASupp
00802526489303 P830060 000
00802526067310 P830060 000
00802526489600 P830060 000
00802526489563 P830060 000
00802526489280 P830060 000
00802526489594 P830060 023
00802526489587 P830060 023
00802526489730 P830060 045
00802526489723 P830060 045
00802526067518 P830060 067
00802526064395 P830060 077
00802526617300 P830060 084
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