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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 PCD TACHYARRHYTHMIA CONTROL SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantMEDTRONIC VASCULAR
PMA NumberP900061
Supplement NumberS066
Date Received06/28/2006
Decision Date07/12/2006
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the prescription label inadvertently omitted from the manuals for the medtronic model 5719 active can emulator (ace) and the model 5460 ace header.
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