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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.
 
DeviceACUITY X4 (Straight,Spiral S, Spiral L) Steroid-eluting, Coronary Venous, QUADRIPOLAR ACE/SENSE LEADS
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantBoston Scientific Corp.
4100 HAMLINE AVE NORTH
ST. PAUL, MN 55112
PMA NumberP010012
Supplement NumberS416
Date Received04/14/2016
Decision Date06/09/2016
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for a shelf-life extension to 18 months.
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