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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 NameCARELINK HOME MONITOR AND CARDIOSIGHT MONITOR
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
Applicant MEDTRONIC INC.
PMA NumberP890003
Supplement NumberS209
Date Received12/22/2010
Decision Date05/04/2011
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for updates to medtronic¿s reveal 2090 application software model sw007 for use with the medtronic reveal implantable cardiac monitor (icm) system.
Approval Order Approval Order
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