RIATA ST MODELS 7000, 7001, 7002, 7010, 7011, & 7012

Implantable Cardioverter Defibrillator (non-crt)

FDA Premarket Approval P950022 S027

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: 1) modifications to the riata st models 7000, 7001 and 7002 active-fixation defibrillation leads to change the geometric profile of the inner coil and add white pigment to the medical adhesive used for shock coil backfill. 2) modifications to the riata st models 7000, 7001, and 7002 leads to create an active-fixation integrated bipolar lead. These devices, as modified, will be marketed under the trade names riata st models 7010, 7011, and 7012 and are indicated for use with compatible pulse generators. 3) modifications to the riata st models 7000, 7001, and 7002 to create a passive fixation and a passive fixation integrated bipolar lead. These devices, as modified, will be marketed under the trade names riata st models 7040, 7041 and 7042 (passive fixation) and riata st models 7050, 7051, 7052 (passive fixation integrated bipolar) and are indicated for use with compatible pulse generators.

DeviceRIATA ST MODELS 7000, 7001, 7002, 7010, 7011, & 7012
Classification NameImplantable Cardioverter Defibrillator (non-crt)
Generic NameImplantable Cardioverter Defibrillator (non-crt)
ApplicantSt. Jude Medical, Inc.
Date Received2006-02-10
Decision Date2006-03-07
PMAP950022
SupplementS027
Product CodeLWS
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address St. Jude Medical, Inc. 15900 Valley View Court sylmar, CA 91342

Supplemental Filings

Supplement NumberDateSupplement Type
P950022Original Filing
S143 2022-07-14 30-day Notice
S142 2021-10-15 Normal 180 Day Track No User Fee
S141 2021-08-02 30-day Notice
S140 2021-07-01 30-day Notice
S139 2021-06-28 30-day Notice
S138 2021-03-12 30-day Notice
S137 2020-11-25 30-day Notice
S136 2020-10-21 30-day Notice
S135 2020-08-11 Real-time Process
S134 2020-06-01 30-day Notice
S133 2020-05-22 30-day Notice
S132 2020-05-08 Normal 180 Day Track No User Fee
S131 2020-03-12 Normal 180 Day Track No User Fee
S130 2020-02-27 30-day Notice
S129 2020-01-27 30-day Notice
S128 2019-09-27 30-day Notice
S127
S126 2018-11-30 30-day Notice
S125 2018-11-23 30-day Notice
S124 2018-11-20 30-day Notice
S123 2018-10-02 30-day Notice
S122 2018-10-01 30-day Notice
S121 2018-09-28 30-day Notice
S120 2018-07-02 30-day Notice
S119 2018-04-02 Real-time Process
S118 2018-03-05 30-day Notice
S117 2018-02-27 30-day Notice
S116 2018-02-26 30-day Notice
S115 2018-01-31 30-day Notice
S114 2018-01-26 30-day Notice
S113 2017-12-21 30-day Notice
S112
S111 2017-09-22 30-day Notice
S110 2017-07-28 Real-time Process
S109 2017-07-03 Normal 180 Day Track
S108 2017-06-27 30-day Notice
S107 2017-06-16 Normal 180 Day Track
S106 2017-05-24 30-day Notice
S105 2017-04-03 Normal 180 Day Track
S104 2017-02-28 30-day Notice
S103 2017-02-24 30-day Notice
S102 2017-02-17 135 Review Track For 30-day Notice
S101 2017-02-10 30-day Notice
S100 2017-01-26 30-day Notice
S099 2017-01-25 30-day Notice
S098 2016-12-13 30-day Notice
S097 2016-11-08 30-day Notice
S096 2016-10-12 30-day Notice
S095 2016-09-27 135 Review Track For 30-day Notice
S094
S093 2016-06-22 30-day Notice
S092 2016-04-12 30-day Notice
S091 2016-01-19 30-day Notice
S090 2015-12-15 30-day Notice
S089 2015-10-26 135 Review Track For 30-day Notice
S088 2015-08-10 30-day Notice
S087 2014-09-29 30-day Notice
S086 2013-05-02 30-day Notice
S085 2012-10-24 Normal 180 Day Track
S084 2012-09-13 30-day Notice
S083 2012-09-05 Real-time Process
S082
S081 2012-01-09 135 Review Track For 30-day Notice
S080 2011-11-30 135 Review Track For 30-day Notice
S079 2011-11-07 Normal 180 Day Track
S078 2011-09-20 Real-time Process
S077 2011-06-20 Real-time Process
S076 2011-01-27 30-day Notice
S075 2010-10-21 Real-time Process
S074 2010-08-16 Normal 180 Day Track No User Fee
S073 2010-07-13 Normal 180 Day Track No User Fee
S072 2010-06-30 135 Review Track For 30-day Notice
S071 2010-06-15 30-day Notice
S070 2010-04-30 Real-time Process
S069 2010-04-22 Normal 180 Day Track
S068 2009-12-24 30-day Notice
S067 2009-11-25 Normal 180 Day Track No User Fee
S066
S065
S064 2009-08-28 30-day Notice
S063 2009-08-04 Real-time Process
S062 2009-06-10 30-day Notice
S061 2009-06-03 30-day Notice
S060 2009-05-14 Real-time Process
S059
S058 2009-02-06 Normal 180 Day Track No User Fee
S057 2009-01-30 30-day Notice
S056 2009-01-21 Normal 180 Day Track No User Fee
S055 2009-01-14 135 Review Track For 30-day Notice
S054 2008-09-29 135 Review Track For 30-day Notice
S053 2008-05-21 30-day Notice
S052 2008-05-07 Real-time Process
S051 2008-02-01 Normal 180 Day Track No User Fee
S050 2008-01-15 30-day Notice
S049 2007-12-03 Normal 180 Day Track No User Fee
S048 2007-11-19 30-day Notice
S047 2007-11-19 30-day Notice
S046 2007-11-05 135 Review Track For 30-day Notice
S045 2007-10-19 Normal 180 Day Track No User Fee
S044
S043 2007-09-20 30-day Notice
S042 2007-09-05 Normal 180 Day Track
S041 2007-08-22 Real-time Process
S040 2007-07-06 Real-time Process
S039 2007-05-10 30-day Notice
S038 2007-05-09 30-day Notice
S037 2007-02-26 30-day Notice
S036 2007-02-26 30-day Notice
S035 2007-02-21 30-day Notice
S034 2006-12-19 Real-time Process
S033 2006-11-15 135 Review Track For 30-day Notice
S032 2006-11-02 Real-time Process
S031 2006-10-16 30-day Notice
S030 2006-06-05 Real-time Process
S029
S028 2006-02-13 Real-time Process
S027 2006-02-10 Real-time Process
S026 2005-08-15 30-day Notice
S025 2005-05-31 Normal 180 Day Track
S024 2005-04-21 Real-time Process
S023 2005-04-05 30-day Notice
S022 2005-04-05 30-day Notice
S021 2005-04-05 30-day Notice
S020 2005-04-05 30-day Notice
S019 2005-03-25 Real-time Process
S018 2004-03-11 Real-time Process
S017 2003-06-09 Real-time Process
S016 2002-12-31 Real-time Process
S015 2002-12-04 Real-time Process
S014 2002-01-31 Real-time Process
S013 2001-08-10 Normal 180 Day Track
S012 2000-12-19 30-day Notice
S011 2000-08-17 Normal 180 Day Track
S010 2000-08-11 Normal 180 Day Track
S009 2000-06-08 Real-time Process
S008 2000-03-20 30-day Notice
S007 1999-12-14 Real-time Process
S006 1999-05-24 Normal 180 Day Track
S005 1999-02-08 Normal 180 Day Track
S004 1998-11-23 Real-time Process
S003 1998-08-20 Normal 180 Day Track
S002 1997-04-14 Normal 180 Day Track
S001 1996-10-15 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
05414734500333 P950022 014
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05414734507271 P950022 085
05414734507288 P950022 085
05414734507295 P950022 085
05414734507486 P950022 085

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