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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.
 
DevicePacemaker Devices: 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 NumberS081
Date Received07/22/2019
Decision Date10/18/2019
Product Codes NVN  LWP 
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for modifying the Model 3300 LATITUDE Programming System software components to update the Brady device application code base, add support for 4G cellular communications, and add an integrated Heart Connect application.
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