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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 NameRAMWARE (BASELINE 15 WITH INC5 RAMWARE) UPDATE TO THE MEDTRONIC ENTRUST 30J/35J ICD SYSTEMS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS053
Date Received08/02/2005
Decision Date08/19/2005
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the ramware (baseline 15 with inc5 ramware) update to the medtronic entrust 30j/35j icd systems for the following models: medtronic entrust model d153atg; medtronic entrust model d153drg; medtronic entrust model d153vrc; medtronic entrust model d154atg; medtronic entrust model d154drg; and medtronic entrust model d154vrc.
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