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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 P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantGUIDANT CORP.
PMA NumberP930035
Supplement NumberS009
Date Received12/01/2000
Decision Date01/23/2001
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 modifications to the model 6942 bi-directional torque wrench.
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