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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.
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
PMA NumberP030054
Supplement NumberS051
Date Received04/06/2007
Decision Date05/07/2007
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the epic and atlas families of icds and crt-ds, including: addition of an over-current protection circuit; added capability for ram operation with rom backup with defibrillation only (dfo) in the hardware backup mode; addition of daily high-voltage lead impedance measurements; addition of lv ring to rv coil pacing pulse configuration; addition of ventricular intrinsic preference feature; and modifications to programmer software and display enhancements. The devices as modified will be marketed under the trade names promote crt-d device model numbers 3107-36 and 3107-30, and current dr and vr icd device model numbers 2107-36, 2107-30 and 1107-36, 1107-30, and will be supported by the model 3650 merlin pcs with model 3330 version 6. 0 software.