MICRONY PACEMAKERS

FDA Premarket Approval P970013 S004

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 modifications to the epic ii/epic ii+ and epic ii hf devices. The modifications include adding a vibratory patient notifier; modifying the electrogram morphology algorithm; modifying the capacitor maintenance feature; changing the materials of the can and header; and minor changes to packaging and software. The devices, as modified, will be marketed under the trade names epic ii/epic ii+ dr/vr/hf implantable cardioverter defibrillator systems (models v-158, v-255, v-258, and v-355) and model 3307 v. 6. 0c software. The model 3307 v. 6. 0m software interfaces with the above noted pmas. The devices are indicated as follows:the epic ii and epic ii+ systems are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. For epic ii+ dr devices, af suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above icd indication and sinus node dysfunction. In patients indicated for an icd, the epic ii hf system is also intended: 1)to provide a reduction of the symptoms of moderate to severe heart failure (nyha functional class iii or iv) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged qrs duration 2) to maintain synchrony of the left and right ventricles in patients who have undergone an av nodal ablation for chronic (permanent) atrial fibrillation and have nyha class ii or iii heart failure.

DeviceMICRONY PACEMAKERS
Generic NamePulse-generator, Single Chamber, Sensor Driven, Implantable
ApplicantSt. Jude Medical, Inc.
Date Received2006-01-25
Decision Date2006-03-14
PMAP970013
SupplementS004
Product CodeLWO 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
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
P970013Original Filing
S091 2022-07-27 Real-time Process
S090 2022-03-07 Real-time Process
S089 2021-10-18 Real-time Process
S088 2021-06-28 30-day Notice
S087 2021-04-02 Real-time Process
S086 2021-03-12 30-day Notice
S085
S084 2020-10-21 30-day Notice
S083 2020-02-13 30-day Notice
S082
S081 2019-10-30 Real-time Process
S080 2018-11-20 30-day Notice
S079 2018-09-28 30-day Notice
S078 2018-07-17 30-day Notice
S077 2018-01-31 30-day Notice
S076 2018-01-18 Normal 180 Day Track
S075 2017-10-30 Real-time Process
S074 2017-10-10 30-day Notice
S073 2017-09-21 30-day Notice
S072 2017-08-16 30-day Notice
S071 2017-05-17 Normal 180 Day Track
S070 2017-02-07 Real-time Process
S069 2016-04-04 Real-time Process
S068
S067 2015-10-26 135 Review Track For 30-day Notice
S066 2015-08-17 Normal 180 Day Track
S065 2015-08-10 30-day Notice
S064 2015-02-11 Normal 180 Day Track
S063 2014-12-18 Real-time Process
S062
S061
S060 2014-07-02 Normal 180 Day Track
S059 2014-05-28 30-day Notice
S058 2014-04-15 Real-time Process
S057 2013-11-21 Normal 180 Day Track
S056 2013-04-15 30-day Notice
S055 2012-12-05 Normal 180 Day Track
S054 2012-11-14 Normal 180 Day Track
S053
S052 2012-09-13 30-day Notice
S051 2012-08-16 Real-time Process
S050 2012-07-11 Normal 180 Day Track
S049 2012-05-30 Real-time Process
S048 2012-04-03 30-day Notice
S047 2012-02-29 Real-time Process
S046
S045 2011-11-30 135 Review Track For 30-day Notice
S044 2011-11-01 Normal 180 Day Track
S043 2011-08-31 Real-time Process
S042 2011-08-08 Real-time Process
S041 2011-06-28 Real-time Process
S040 2011-05-02 Normal 180 Day Track
S039 2011-02-28 30-day Notice
S038 2010-11-23 Normal 180 Day Track
S037 2010-10-12 30-day Notice
S036 2010-08-16 Normal 180 Day Track No User Fee
S035 2010-07-30 Real-time Process
S034 2010-06-04 Normal 180 Day Track
S033 2010-05-21 30-day Notice
S032 2009-10-02 135 Review Track For 30-day Notice
S031 2009-09-14 Real-time Process
S030 2009-06-18 30-day Notice
S029 2009-06-10 30-day Notice
S028 2008-12-31 Real-time Process
S027 2008-07-30 Real-time Process
S026 2008-06-13 30-day Notice
S025 2008-06-02 Real-time Process
S024 2008-05-21 30-day Notice
S023 2008-03-25 Real-time Process
S022 2007-10-24 Real-time Process
S021 2007-10-19 Normal 180 Day Track No User Fee
S020 2007-09-21 Real-time Process
S019 2007-04-23 Normal 180 Day Track
S018 2007-04-13 Real-time Process
S017 2007-04-06 Real-time Process
S016 2006-12-22 135 Review Track For 30-day Notice
S015 2006-12-20 135 Review Track For 30-day Notice
S014 2006-10-20 Real-time Process
S013 2006-10-06 Real-time Process
S012 2006-09-27 30-day Notice
S011 2006-07-13 30-day Notice
S010 2006-06-07 Real-time Process
S009
S008 2006-03-30 Real-time Process
S007 2006-03-07 Real-time Process
S006 2006-02-17 Normal 180 Day Track
S005 2006-02-03 Real-time Process
S004 2006-01-25 Normal 180 Day Track
S003 2006-01-06 Real-time Process
S002 2001-09-28 30-day Notice
S001 2001-03-13 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
05414734006224 P970013 036

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