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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.
 
DeviceCONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP010012
Supplement NumberS603
Date Received01/28/2026
Decision Date03/06/2026
Product Code NIK 
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 the related transfer of the downstream final packaging process from the Boston Scientific Puerto Rico Dorado site to Boston Scientific Quincy, Massachusetts facility to enable regionally co-located operations for the CRM leads.
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