IsoFlex Optim

FDA Premarket Approval P960030 S074

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

To adjust sample size for bacterial endotoxin testing

DeviceIsoFlex Optim
Generic NameDrug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
ApplicantSt. Jude Medical
Date Received2021-03-12
Decision Date2021-04-09
PMAP960030
SupplementS074
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
S074 2021-03-12 30-day Notice
S073 2021-02-19 30-day Notice
S072 2020-11-25 30-day Notice
S071 2020-10-21 30-day Notice
S070 2020-08-11 Real-time Process
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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