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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(R) PRIZM(TM) DR/VR HE SYSTEM
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable cardioverter pulse generator and program software
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS016
Date Received06/29/2000
Decision Date08/07/2000
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the high energy automatic implantable cardiovascular defibrillator (aicd) system, models 1852, 1853, 1857, and 1858.
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