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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: 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.
 
DeviceCAPSUREFIX NOVUS MRI SURESCAN
Classification Namepermanent defibrillator electrodes
Generic Namepermanent defibrillator electrodes
Applicant
Medtronic, Inc.
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP930039
Supplement NumberS140
Date Received09/24/2015
Decision Date02/01/2016
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI/Compia MRI Quad CRT-D SureScan devices, programmer application software Model SW034 and extension of MR Conditional labeling for the Attain Ability and Attain Performa lead models as MRI SureScan labeled leads.
Post-Approval StudyShow Report Schedule and Study Progress
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