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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.
 
DeviceINGEVITY and INGEVITY MRI Leads and Accessories; VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBOSTONSCIENTIFIC
4100 HAMLINE AVENUE NORTH
ST PAUL, MN 55112
PMA NumberP150012
Supplement NumberS107
Date Received03/08/2021
Decision Date04/02/2021
Product Codes LWP NVN 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Implement the Global Labeling System version 3.0 at select locations.
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