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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 NameDELTA/VISTA PACEMAKERS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namemplantable cardioverter defibrillator
ApplicantGUIDANT CORP.
PMA NumberP910077
Supplement NumberS029
Date Received10/06/1999
Decision Date11/05/1999
Product Code
LWS[ Registered Establishments with LWS ]
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 modifications to the programmer software model 2881 version 1. 3 and its labeling, used with the model 2950 and 2901 prm programmers, to correct software anomalies and update features.
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