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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.
 
DeviceDIVA FAMILY INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE 11, VITA DDDR, VITA DDD AND VITA VVIR
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
MEDTRONIC Inc.
8200 coral sea street
ms mvs11
mounds view, MN 55112
PMA NumberP980050
Supplement NumberS082
Date Received04/18/2013
Decision Date06/11/2013
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
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