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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.
 
DeviceImplantable Pulse Generator Test Magnet
Generic NamePacemaker/icd/crt non-implanted components
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP830060
Supplement NumberS084
Date Received02/24/2021
Decision Date04/16/2021
Product Code OSR 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Suzhou Jenitek Medical Co., Ltd. (Jenitek), No.70 Emeishan Road, SND, Suzhou, Jiangsu, China for finished device manufacturing.
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