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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.
 
DeviceAccolade Family of Devices Pacemakers, and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps)
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP150012
Supplement NumberS134
Date Received10/26/2022
Decision Date12/12/2022
Product Codes LWP NVN 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modifications to the product labeling for the Accolade family of pacemakers and cardiac resynchronization therapy pacemakers to provide additional clarity.
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