CardioMEMS HF System

FDA Premarket Approval P100045 S061

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

DeviceCardioMEMS HF System
Generic NameSystem, Hemodynamic, Implantable
ApplicantSt. Jude Medical387 Technology Circle Nwsuite 500atlanta, GA 30313 PMA NumberP100045 Supplement NumberS061 Date Received03/03/2022 Decision Date03/31/2022 Product Code MOM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-03-03
Decision Date2022-03-31
PMAP100045
SupplementS061
Product CodeMOM 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressSt. Jude Medical
387 Technology Circle Nw
suite 500
atlanta, GA 30313 PMA NumberP100045 Supplement NumberS061 Date Received03/03/2022 Decision Date03/31/2022 Product Code MOM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
alternate, Drop-in Replacement Printed Circuit Board Assembly Components For Use With The CardioMEMS CM3100 Hospital System

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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