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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.
 
DeviceMulticenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT)
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP010012
Supplement NumberS570
Date Received05/08/2023
Decision Date10/19/2023
Product Code NIK 
Advisory Committee Cardiovascular
Clinical TrialsNCT00180271
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
updated labeling to include information regarding the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) Post Approval Studies [ (PAS 1) PAS for the MADIT-CRT Indicated Patient Population, Utilizing Data from the NCDR ICD Registry; (PAS 2) Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy Post Approval Registry]
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