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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 NameCADET V-105 "C" AND "D" AND V-115 "C" AND "D" PULSE GENERATORS & SOFTWARE VERSION 4.1 FOR THE PROGRAMMER MDL PR-1500
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametherapy defibrillation system
ApplicantVENTRITEX, INC.
PMA NumberP910023
Supplement NumberS012
Date Received06/30/1995
Decision Date12/22/1995
Product Code
LWS[ Registered Establishments with LWS ]
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 cadence tiered therapy defibrillator system with "c" and "d" header styles for cadet v-105 and v-115, and programmer model pr-1500 software version 4. 1.
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