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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 NameCONVERT (MODEL V-191) AND CONVERT+ (MODEL V-195) SYSTEMS WITH APPLICATION SOFTWARE MODEL 3307 VERSION 4.9
Classification Namepulse generator, permanent, implantable
Generic Nametranstelephonic follow-up/monitoring system
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP910023
Supplement NumberS081
Date Received08/08/2005
Decision Date05/11/2006
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the convert and convert+ icd systems with the application software model 3307 version 4. 9. The device, as modified, will be marketed under the trade name convert and convert+ icd systems and is indicated to provide ventricular antitachycardia pacing (model v-195 only) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
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