CardioMEMS HF System

FDA Premarket Approval P100045 S058

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 updates to the temperature sensitivity manufacturing process

DeviceCardioMEMS HF System
Generic NameSystem, Hemodynamic, Implantable
ApplicantSt. Jude Medical
Date Received2021-08-17
Decision Date2021-09-16
PMAP100045
SupplementS058
Product CodeMOM 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address St. Jude Medical 387 Technology Circle Nw suite 500 atlanta, GA 30313

Supplemental Filings

Supplement NumberDateSupplement Type
P100045Original Filing
S058 2021-08-17 30-day Notice
S057
S056
S055 2021-06-04 30-day Notice
S054
S053
S052
S051 2021-03-25 30-day Notice
S050 2021-03-09 Normal 180 Day Track No User Fee
S049
S048 2021-02-10 30-day Notice
S047 2020-12-15 Real-time Process
S046 2020-12-03 30-day Notice
S045 2020-07-15 30-day Notice
S044 2020-06-29 30-day Notice
S043
S042 2020-03-18 30-day Notice
S041 2019-11-07 Real-time Process
S040 2019-10-18 30-day Notice
S039 2019-03-13 30-day Notice
S038 2019-02-19 30-day Notice
S037 2019-01-31 30-day Notice
S036 2019-01-08 Real-time Process
S035 2018-10-29 Real-time Process
S034 2018-10-09 Real-time Process
S033 2018-10-09 30-day Notice
S032 2018-09-24 30-day Notice
S031 2018-07-20 30-day Notice
S030 2018-06-29 30-day Notice
S029 2018-06-12 30-day Notice
S028 2018-01-29 30-day Notice
S027
S026
S025 2017-10-12 Real-time Process
S024 2017-08-10 30-day Notice
S023 2017-07-17 Real-time Process
S022 2017-07-12 Normal 180 Day Track No User Fee
S021
S020 2017-05-19 30-day Notice
S019 2017-01-10 135 Review Track For 30-day Notice
S018 2016-12-15 Normal 180 Day Track No User Fee
S017 2016-11-23 135 Review Track For 30-day Notice
S016 2016-11-22 30-day Notice
S015 2016-11-18 135 Review Track For 30-day Notice
S014 2016-11-17 Real-time Process
S013 2016-10-31 30-day Notice
S012 2016-10-17 Special (immediate Track)
S011 2016-09-30 Special (immediate Track)
S010 2016-08-01 30-day Notice
S009 2016-04-26 Real-time Process
S008 2016-03-15 Normal 180 Day Track No User Fee
S007 2015-09-04 Real-time Process
S006 2015-08-21 Normal 180 Day Track No User Fee
S005 2015-04-28 30-day Notice
S004 2015-02-04 Real-time Process
S003
S002 2014-11-26 Normal 180 Day Track
S001 2014-06-30 Normal 180 Day Track No User Fee

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