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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 MINI IV (AICD)
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameprogrammer recorder monitor (prm) for implantable pulse generators
ApplicantGUIDANT CORP.
PMA NumberP910077
Supplement NumberS035
Date Received11/07/2000
Decision Date12/06/2000
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 the modification of the mini(tm) iv aicd(tm) header and removing the sterile mineral oil and hex wrench from the package.
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