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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 NameGUIDANT PULSE GENERATORS
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantGUIDANT CORP.
PMA NumberP830060
Supplement NumberS058
Date Received05/27/2005
Decision Date06/20/2005
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional instruction for use for freeing stuck setscrews using the bi-directional torque wrench.
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