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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 PRIZM DR/VR AND VENTAK PRIZM DR/VR HE ACID SYSTEMS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS023
Date Received06/06/2001
Decision Date06/27/2001
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing and sterilization facility located at guidant ireland, clonmel tipperary, ireland and alternate sterilization facilities located at isotron ireland ltd. , offaly, ireland and guidant, st. Paul, minnesota.
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