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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 NameVENTRITEX CONTOUR II/MD; ANGSTROM II/MD; PROFILE II/MD TIERED THERAPY IMPLANTABLE DEFIBRILLATOR
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametiered therapy implantable defibrillator
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP910023
Supplement NumberS042
Date Received03/31/1999
Decision Date04/19/1999
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change to reflect compatibility of the contour ii/md, angstrom ii/md, and profile ii/md implantable defibrillators with cellular phones.
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