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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 NameVISTATRON C&T SERIES (MODEL VSF04 V8.0, MODEL VSF 12 V8.0, MODEL VSF08 V8.0)
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pacemaker pulse generator
Applicant MEDTRONIC INC.
PMA NumberP990001
Supplement NumberS105
Date Received07/17/2012
Decision Date03/13/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for the vitatron desktop software application.
Approval Order Approval Order
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