CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM

System, Hemodynamic, Implantable

FDA Premarket Approval P100045

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the cardiomems hf system, which includes the cm2000 implantable pa sensor/monitor and transvenous catheter delivery system, the cm1000 patient electronics system (gsm), thecm1010 patient electronics system (gsm), and cm3000 hospital electronics system. This device is indicated for wirelessly measuring and monitoring pulmonary artery (pa) pressure and heart rate in new york heart association (nyha) class iii heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.

DeviceCARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
Classification NameSystem, Hemodynamic, Implantable
Generic NameSystem, Hemodynamic, Implantable
ApplicantSt. Jude Medical
Date Received2010-12-15
Decision Date2014-05-28
Notice Date2014-06-10
PMAP100045
SupplementS
Product CodeMOM
Docket Number14M-0727
Advisory CommitteeCardiovascular
Expedited ReviewYes
Combination Product No
Applicant Address St. Jude Medical 387 Technology Circle Nw suite 500 atlanta, GA 30313
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P100045Original Filing
S064 2022-12-09 30-day Notice
S063 2022-08-18 Normal 180 Day Track No User Fee
S062 2022-03-14 30-day Notice
S061 2022-03-03 30-day Notice
S060 2022-02-02 30-day Notice
S059
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

NIH GUDID Devices

Device IDPMASupp
05414734509299 P100045 000
05414734509190 P100045 000
05414734509213 P100045 000
05414734509251 P100045 000
05414734509275 P100045 000
05414734509282 P100045 000
05414734509268 P100045 000
05414734509312 P100045 000
05414734509398 P100045 000
05414734509909 P100045 000
05414734509916 P100045 000
05414734509923 P100045 000
05414734509978 P100045 000
05414734510257 P100045 000
05414734509220 P100045 000
05414734509206 P100045 000
05414734509183 P100045 000
05415067034915 P100045 049
05415067034731 P100045 049
05415067034724 P100045 049
05415067034724 P100045 059

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