Myocardial Pacing Lead 510(k) FDA Approval

Device	Myocardial Pacing Lead
Generic Name	Permanent Pacemaker Electrode
Applicant	MEDTRONIC 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 Received	2022-04-14
Decision Date	2022-04-21
PMA	P120017
Supplement	S030
Product Code	DTB
Advisory Committee	Cardiovascular
Supplement Type	30-day Notice
Supplement Reason	Process Change - Manufacturer/sterilizer/packager/supplier
Expedited Review	No
Combination Product	No
Applicant Address	MEDTRONIC 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

Myocardial Pacing Lead