Assurity MRI, Endurity MRI, MRI Activator, and Tendril MRI

FDA Premarket Approval P140033 S055

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

To adopt sterilization recipe cycle pg 600 for the abbott penang malaysia manufacturing facility

DeviceAssurity MRI, Endurity MRI, MRI Activator, and Tendril MRI
ApplicantSt. Jude Medical, Inc.
Date Received2020-02-13
Decision Date2020-02-28
PMAP140033
SupplementS055
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address St. Jude Medical, Inc. 15900 Valley View Court sylmar, CA 91342

Supplemental Filings

Supplement NumberDateSupplement Type
P140033Original Filing
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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