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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 NameVENTRITEX ICD'S
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber implantable cardioverter defibrillator
ApplicantST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
PMA NumberP910023
Supplement NumberS049
Date Received11/02/2000
Decision Date11/27/2000
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 model 3510 programmer and software model 3307 (v2. 0).
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