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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 NameHEX WRENCH(MODEL 6501)
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantGUIDANT CORP.
PMA NumberP930035
Supplement NumberS011
Date Received10/30/2003
Decision Date11/21/2003
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change to include text versions and more descriptive application diagrams for using the bi-directional torque wrench (model 6942) and hex wrench (model 6501). The new labeling also specified that the device is sterilized, non-pyrogenic and single use only.
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