Assurity MRI, Endurity MRI, and Zenus MRI

FDA Premarket Approval P140033 S073

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

DeviceAssurity MRI, Endurity MRI, and Zenus MRI
Generic NameImplantable Pulse Generator, Pacemaker (non-crt)
ApplicantAbbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP140033 Supplement NumberS073 Date Received07/01/2022 Decision Date07/14/2022 Product Codes LWP NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-07-01
Decision Date2022-07-14
PMAP140033
SupplementS073
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressAbbott Medical
15900 Valley View Court
sylmar, CA 91335 PMA NumberP140033 Supplement NumberS073 Date Received07/01/2022 Decision Date07/14/2022 Product Codes LWP NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
a Second-tier Supplier's Manufacturing Site Transfer

Supplemental Filings

Supplement NumberDateSupplement Type
P140033Original Filing
S074 2022-07-14 30-day Notice
S073 2022-07-01 30-day Notice
S072 2022-03-07 Real-time Process
S071 2021-10-18 Real-time Process
S070 2021-07-08 Normal 180 Day Track
S069 2021-06-28 30-day Notice
S068
S067 2021-04-02 Real-time Process
S066 2021-03-12 30-day Notice
S065
S064 2020-11-25 30-day Notice
S063 2020-10-21 30-day Notice
S062
S061 2020-09-30 30-day Notice
S060
S059 2020-05-22 30-day Notice
S058 2020-04-24 30-day Notice
S057 2020-04-23 Normal 180 Day Track No User Fee
S056 2020-02-27 30-day Notice
S055 2020-02-13 30-day Notice
S054
S053 2019-12-10 30-day Notice
S052 2019-12-09 30-day Notice
S051 2019-11-25 30-day Notice
S050
S049
S048
S047 2019-09-26 30-day Notice
S046 2019-07-31 30-day Notice
S045 2019-05-01 30-day Notice
S044 2018-11-30 30-day Notice
S043 2018-11-23 30-day Notice
S042 2018-11-20 30-day Notice
S041 2018-10-29 Real-time Process
S040 2018-10-02 30-day Notice
S039 2018-10-01 30-day Notice
S038 2018-09-28 30-day Notice
S037 2018-09-04 30-day Notice
S036 2018-07-17 30-day Notice
S035 2018-07-02 30-day Notice
S034 2018-06-28 Normal 180 Day Track
S033 2018-06-20 Normal 180 Day Track
S032 2018-05-21 30-day Notice
S031
S030 2018-05-01 30-day Notice
S029 2018-04-10 30-day Notice
S028 2018-04-05 30-day Notice
S027 2018-02-27 30-day Notice
S026 2018-02-07 30-day Notice
S025 2018-01-31 30-day Notice
S024 2018-01-29 30-day Notice
S023 2018-01-22 Real-time Process
S022 2018-01-18 Normal 180 Day Track
S021
S020 2017-11-29 30-day Notice
S019 2017-11-08 Real-time Process
S018 2017-11-07 Normal 180 Day Track
S017 2017-10-30 Real-time Process
S016 2017-10-10 30-day Notice
S015 2017-09-21 30-day Notice
S014 2017-09-18 135 Review Track For 30-day Notice
S013 2017-08-16 30-day Notice
S012 2017-08-01 Real-time Process
S011 2017-07-31 30-day Notice
S010 2017-07-03 Normal 180 Day Track
S009 2017-06-30 30-day Notice
S008 2017-05-17 Normal 180 Day Track
S007 2017-04-06 30-day Notice
S006 2017-04-03 Normal 180 Day Track
S005 2017-03-06 30-day Notice
S004 2017-02-28 30-day Notice
S003 2017-02-24 30-day Notice
S002 2017-02-17 135 Review Track For 30-day Notice
S001 2017-02-08 30-day Notice

NIH GUDID Devices

Device IDPMASupp
05414734509602 P140033 000
05414734509596 P140033 000
05414734509589 P140033 000
05414734509572 P140033 000
05414734504683 P140033 000
05414734504638 P140033 000
05414734504621 P140033 000
05414734503648 P140033 000
05414734510059 P140033 012

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