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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 MRI SURESCAN
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
Medtronic, Inc
8200 coral sea street ne
mounds view, MN 55112
PMA NumberP090013
Supplement NumberS202
Date Received09/24/2015
Decision Date02/01/2016
Product Code
LWP[ Registered Establishments with LWP ]
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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