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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.
 
DevicePacemakers: Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, and Accolade MRI
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
BOSTONSCIENTIFIC
4100 hamline avenue north
st paul, MN 55112
PMA NumberP150012
Supplement NumberS037
Date Received09/05/2017
Decision Date09/25/2017
Product Codes NVN  LWP 
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 
Modify the quartz crystal component manufacturing process.
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