CardioMEMS HF System

FDA Premarket Approval P100045 S046

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

Rework the lcd screens from the cardiomems i3 patient electronic system (pes) returns inventory and use them in the new pes manufacturing builds

DeviceCardioMEMS HF System
Generic NameSystem, Hemodynamic, Implantable
ApplicantSt. Jude Medical
Date Received2020-12-03
Decision Date2020-12-22
PMAP100045
SupplementS046
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
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

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.