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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 NameST. JUDE MEDICAL EPIC II/EPIC II + AND ATLAS II/ATLAS II + ICDS AND CRT-D SYSTEMS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedual chamber implantable cardioverter defibrillator with biventricular pacing
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS045
Date Received11/21/2006
Decision Date12/13/2006
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following modifications to the icd/crt-d device hybrid: 1) addition of a new c64 micro controller integrated circuit (ic); 2) changes to the c46 vss supply capacitor from 3. 3 uf to 33 uf; and 3) changes to diodes d17, d19 and d23 in the protection circuit.
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