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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 NameMEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) PRODUCT
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantMEDTRONIC VASCULAR
PMA NumberP900061
Supplement NumberS054
Date Received12/18/2002
Decision Date01/06/2003
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing and packaging facility located at medtronic arizona device manufacturing, tempe, arizona.
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