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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 NameVENTAK PRX AND VENTAK MINI SYSTEMS
Classification Namepacemaker/icd/crt non-implanted components
Generic Nameimplantable cardioverter defibrillator systems
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP910077
Supplement NumberS144
Date Received06/09/2014
Decision Date08/12/2014
Product Code
OSR[ Registered Establishments with OSR ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for model 2909 multiple application utility system software v9. 03 and model 2905 pdf report generation software v1. 02 which reside on the zoom latitude programming system model 3120.
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