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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameINSYNC FAMILIES OF ICD & CONCERTO ICD & CONSULTA CRT-D & MAXIMO II CRT-D
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS109
Date Received07/02/2008
Decision Date01/06/2009
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing the manufacturing process of a rectifier diode and a thyristor.
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