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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.
 
DeviceESSENTIO, PROPONENT, ACCOLADE, INGEVITY MRI'S & SLIT SUTURE SLEEVE ACCESSORY (FOR INGEVITY MRI LEADS)
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
BOSTONSCIENTIFIC
4100 hamline avenue north
st paul, MN 55112
PMA NumberP150012
Supplement NumberS021
Date Received12/09/2016
Decision Date04/11/2017
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 Yes
Approval Order Statement 
Approval for the addition of 3T MR Conditional labeling for the Image Ready MR Conditional Pacing System consisting of an Accolade MRI pacemaker with one or two INGEVITY MRI leads. Approval to expand the Image Ready System to include 1.5T MR Conditional labeling for the FINELINE II Sterox and Sterox EZ leads.
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