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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 NameAPPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A)
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namepacemaker programmer software
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP910023
Supplement NumberS063
Date Received12/24/2002
Decision Date01/22/2003
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 model 3307 (version 4. 1a) programmer software for sjm models 3500/3510 programmer.
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