Micra Transcatheter Pacing System

Leadless Pacemaker

FDA Premarket Approval P150033 S060

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 add medtronic ireland as an alternative site for completing the finished device analytical lot release testing

DeviceMicra Transcatheter Pacing System
Classification NameLeadless Pacemaker
Generic NameLeadless Pacemaker
ApplicantMEDTRONIC Inc.
Date Received2019-10-24
Decision Date2019-11-21
PMAP150033
SupplementS060
Product CodePNJ
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address MEDTRONIC Inc. 8200 Coral Sea Street Ne ms Mv S11 mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P150033Original Filing
S060 2019-10-24 30-day Notice
S059 2019-09-27 Real-time Process
S058 2019-09-17 30-day Notice
S057 2019-09-16 30-day Notice
S056 2019-09-16 30-day Notice
S055 2019-06-10 30-day Notice
S054 2019-04-11 30-day Notice
S053 2019-03-28 30-day Notice
S052
S051
S050
S049 2019-02-26 30-day Notice
S048 2019-01-23 30-day Notice
S047 2018-11-27 30-day Notice
S046 2018-10-23 30-day Notice
S045 2018-10-18 30-day Notice
S044 2018-10-15 30-day Notice
S043 2018-10-09 30-day Notice
S042 2018-09-26 30-day Notice
S041 2018-08-22 Real-time Process
S040 2018-08-08 30-day Notice
S039 2018-06-28 Normal 180 Day Track No User Fee
S038 2018-07-06 Real-time Process
S037
S036 2018-04-17 Real-time Process
S035 2018-04-12 30-day Notice
S034 2018-04-09 30-day Notice
S033 2018-03-12 30-day Notice
S032 2018-02-01 Real-time Process
S031 2018-01-30 30-day Notice
S030 2018-01-17 30-day Notice
S029 2017-12-22 30-day Notice
S028 2017-11-20 30-day Notice
S027 2017-09-05 Real-time Process
S026 2017-07-28 30-day Notice
S025 2017-06-23 30-day Notice
S024 2017-06-09 30-day Notice
S023 2017-05-12 30-day Notice
S022 2017-03-31 30-day Notice
S021 2017-03-29 30-day Notice
S020 2017-03-13 Real-time Process
S019 2017-03-03 30-day Notice
S018 2017-02-21 Real-time Process
S017 2017-02-17 30-day Notice
S016 2017-02-02 30-day Notice
S015 2017-02-01 Normal 180 Day Track
S014 2017-01-13 30-day Notice
S013 2016-11-23 Real-time Process
S012 2016-11-16 Normal 180 Day Track
S011 2016-11-14 30-day Notice
S010 2016-10-07 30-day Notice
S009 2016-09-30 Real-time Process
S008 2016-09-29 30-day Notice
S007 2016-09-26 30-day Notice
S006 2016-07-22 30-day Notice
S005 2016-07-22 30-day Notice
S004 2016-07-01 30-day Notice
S003 2016-05-23 Real-time Process
S002 2016-05-06 Real-time Process
S001 2016-04-29 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00643169529748 P150033 000
00643169529748 P150033 000
00643169711761 P150033 015
00643169711761 P150033 015

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