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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 MRI, INGEVITY+
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP150012
Supplement NumberS139
Date Received01/19/2023
Decision Date04/19/2023
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 the replacement of raw material Elasthane 55D MR supplied by DSM with Pellethane 2363 55D supplied by Lubrizol Advanced Materials, Inc for use in the polyurethane outer insulation tubing for the INGEVITY MRI and INGEVITY+ leads.
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