Microny

FDA Premarket Approval P970013 S084

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 the minimum relative humidity from 40% to 35% in the product packaging area

DeviceMicrony
Generic NamePulse-generator, Single Chamber, Sensor Driven, Implantable
ApplicantSt. Jude Medical, Inc.
Date Received2020-10-21
Decision Date2020-10-26
PMAP970013
SupplementS084
Product CodeLWO 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
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

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