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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 MRI SR, Essentio MRI DR, Essentio MRI EL DR, Proponent, Accolade MRI SR, Accolade MRI DR and Accolade MRI EL DR
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
BOSTONSCIENTIFIC
4100 hamline avenue north
st paul, MN 55112
PMA NumberP150012
Supplement NumberS087
Date Received12/03/2019
Decision Date12/04/2019
Product Codes LWP  NVN 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Add a post-reflow manufacturing inspection for printed circuit boards.
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