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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 NameDIVA FAMILY (INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE II, VITA DDDR, VITA DDD AND VITA VVIR) DEMA FAMILY (INCLUDES
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pacemaker pulse generator
ApplicantMEDTRONIC, INC.
PMA NumberP990001
Supplement NumberS118
Date Received07/02/2014
Decision Date09/05/2014
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
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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