Isoflex

FDA Premarket Approval P960030 S069

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

Inclusion of abbott soal and abbott re tem as alternate test sites; use of a distal subassembly as a surrogate stability test article; and an update to the annual stability protocol

DeviceIsoflex
Generic NameDrug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
ApplicantSt. Jude Medical
Date Received2020-05-22
Decision Date2020-06-18
PMAP960030
SupplementS069
Product CodeNVN 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address St. Jude Medical 15900 Valley View Ct. p.o. Box 9221 sylmar, CA 91392-9221

Supplemental Filings

Supplement NumberDateSupplement Type
P960030Original Filing
S069 2020-05-22 30-day Notice
S068 2020-02-27 30-day Notice
S067 2019-09-26 30-day Notice
S066
S065 2018-11-30 30-day Notice
S064 2018-11-23 30-day Notice
S063 2018-11-20 30-day Notice
S062 2018-10-02 30-day Notice
S061 2018-10-01 30-day Notice
S060 2018-09-28 30-day Notice
S059 2018-07-02 30-day Notice
S058 2018-03-05 30-day Notice
S057 2018-02-27 30-day Notice
S056 2018-01-31 30-day Notice
S055 2018-01-26 30-day Notice
S054 2017-02-28 30-day Notice
S053 2017-02-24 30-day Notice
S052 2017-02-17 135 Review Track For 30-day Notice
S051 2017-02-10 30-day Notice
S050 2017-01-25 30-day Notice
S049 2016-12-13 30-day Notice
S048 2016-10-12 30-day Notice
S047 2016-09-27 135 Review Track For 30-day Notice
S046
S045 2016-06-22 30-day Notice
S044 2016-04-12 30-day Notice
S043 2016-04-04 30-day Notice
S042 2016-01-21 30-day Notice
S041 2016-01-19 30-day Notice
S040 2015-10-26 135 Review Track For 30-day Notice
S039 2015-08-10 30-day Notice
S038 2013-09-05 30-day Notice
S037 2012-09-13 30-day Notice
S036 2012-04-03 30-day Notice
S035 2012-02-14 Real-time Process
S034 2011-11-30 135 Review Track For 30-day Notice
S033 2011-04-04 30-day Notice
S032 2010-08-16 Normal 180 Day Track No User Fee
S031 2010-05-20 Normal 180 Day Track
S030 2010-04-13 30-day Notice
S029 2009-12-24 30-day Notice
S028 2009-11-25 Normal 180 Day Track No User Fee
S027 2009-08-28 30-day Notice
S026 2009-06-10 30-day Notice
S025 2009-01-30 30-day Notice
S024 2008-10-29 30-day Notice
S023 2008-08-26 Normal 180 Day Track No User Fee
S022 2008-05-21 30-day Notice
S021 2008-02-01 Normal 180 Day Track No User Fee
S020 2008-01-17 Real-time Process
S019 2007-10-19 Normal 180 Day Track No User Fee
S018 2007-09-28 30-day Notice
S017 2007-09-24 30-day Notice
S016 2007-03-05 Real-time Process
S015 2007-02-26 135 Review Track For 30-day Notice
S014 2007-02-08 30-day Notice
S013 2005-09-09 Real-time Process
S012 2004-08-03 Normal 180 Day Track
S011 2004-07-16 Normal 180 Day Track No User Fee
S010 2003-02-11 Real-time Process
S009 2002-12-04 Real-time Process
S008 2000-11-16 Real-time Process
S007 2000-08-11 Normal 180 Day Track
S006 1999-07-02 135 Review Track For 30-day Notice
S005 1999-04-01 Normal 180 Day Track
S004 1998-09-16 30-day Notice
S003 1998-09-15 30-day Notice
S002
S001

NIH GUDID Devices

Device IDPMASupp
05414734502351 P960030 020
05414734502344 P960030 020
05414734502337 P960030 020
05414734502320 P960030 020
05414734502313 P960030 020

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