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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 NameSWEET TIP
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namebipolar endocardial leads
ApplicantGUIDANT CORP.
PMA NumberP830060
Supplement NumberS044
Date Received11/20/1998
Decision Date12/08/1998
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of a larger diameter wire helix in the lead's tip electrode, and associated labeling changes.
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