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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 NameINTERMEDICS MICRON IMPLANTABLE DEFIBRILLATORS
Generic Nameimplantable cardioverter defibrillator (icd) lead
ApplicantGUIDANT CORP.
PMA NumberP940008
Supplement NumberS016
Date Received03/27/2001
Decision Date04/25/2001
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to the follow-up indicators reflecting battery longevity.
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