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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, PROPONENT MRI, ACCOLADE MRI
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBOSTONSCIENTIFIC
4100 HAMLINE AVENUE NORTH
ST PAUL, MN 55112
PMA NumberP150012
Supplement NumberS018
Date Received11/03/2016
Decision Date11/30/2016
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  
Addition of an alternate supplier of titanium for pulse generator case halves.
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