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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.
 
DeviceCRT-Ds (Cardiac Resynchronization Therapy Defibrillator),Platinium CRT-D 1711, 01741
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP060027
Supplement NumberS087
Date Received08/23/2016
Decision Date09/21/2016
Product Code NIK 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Alternate manufacturing flow sequence, the addition of new dispensing equipment and an optional step in the manufacturing line for the microelectronic and electronic assembly.
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