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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCAPSURE VDD-2 LEAD
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Applicant
Medtronic, Inc.
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP890003
Supplement NumberS290
Date Received10/24/2013
Decision Date01/22/2014
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR USE OF NEW SILICONE INSULATION TUBING MATERIALS.
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