Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NameCURRENT ICD; EPIC HF/ ATLAS + HF FAMILY OF CRT-DS
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 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 - component
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.
-
-