Myocardial Pacing Lead

FDA Premarket Approval P120017 S030

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

DeviceMyocardial Pacing Lead
Generic NamePermanent Pacemaker Electrode
ApplicantMEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP120017 Supplement NumberS030 Date Received04/14/2022 Decision Date04/21/2022 Product Code DTB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-14
Decision Date2022-04-21
PMAP120017
SupplementS030
Product CodeDTB 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressMEDTRONIC Inc.
8200 Coral Sea Street Ne
ms Mv S11
mounds View, MN 55112 PMA NumberP120017 Supplement NumberS030 Date Received04/14/2022 Decision Date04/21/2022 Product Code DTB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
updates To The Equipment Used For Monitoring Temperature And Humidity In Controlled Environment Area Number 2 At Medtronic Rice Creek

Supplemental Filings

Supplement NumberDateSupplement Type
P120017Original Filing
S030 2022-04-14 30-day Notice
S029 2021-11-18 30-day Notice
S028 2021-08-09 30-day Notice
S027 2021-02-05 30-day Notice
S026 2020-12-01 30-day Notice
S025 2020-11-24 30-day Notice
S024 2020-10-23 30-day Notice
S023 2020-07-09 30-day Notice
S022 2020-06-26 30-day Notice
S021 2020-03-23 Real-time Process
S020 2019-11-18 30-day Notice
S019 2019-09-16 30-day Notice
S018 2019-06-10 30-day Notice
S017 2019-02-28 30-day Notice
S016 2018-10-23 30-day Notice
S015 2018-10-18 30-day Notice
S014 2018-09-26 30-day Notice
S013 2018-05-15 30-day Notice
S012 2018-02-22 30-day Notice
S011 2017-11-20 30-day Notice
S010 2017-08-07 30-day Notice
S009 2017-06-28 30-day Notice
S008 2017-06-07 30-day Notice
S007 2016-11-14 30-day Notice
S006 2016-10-05 30-day Notice
S005 2016-08-25 30-day Notice
S004 2016-06-24 30-day Notice
S003 2015-12-28 30-day Notice
S002 2015-12-22 30-day Notice
S001 2015-09-10 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00643169638624 P120017 000
00643169638617 P120017 000
00643169638600 P120017 000
00643169638594 P120017 000

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