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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.
 
DeviceINGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP150012
Supplement NumberS116
Date Received09/03/2021
Decision Date11/30/2021
Product Codes LWP NVN 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a software maintenance release (SMR) to the Model 3300 LATITUDE Programming System and the release of the Model 3894 LATITUDE Consult software application.
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