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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 NameCONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS169
Date Received10/08/2009
Decision Date01/13/2010
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at medtronic swiss manufacturing operations in tolochenaz, switzerland to perform final packaging for the device.
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