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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEPIC HF FAMILY CRT-DS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Applicant
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
PMA NumberP030054
Supplement NumberS122
Date Received04/02/2009
Decision Date05/07/2009
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:1) REPLACING THE EXISTING HAND SOLDER INTERCONNECTIONS BETWEEN SUBASSEMBLIES WITHPLUG/RECEPTACLE CONNECTORS, EPOXY, DIRECT SOLDER OR LASER WELDING.2) USING AN ORGANIC SUBSTRATE FOR THE HYBRID MODULE.3) RECONFIGURING DISCRETE SURFACE MOUNT MAGNETIC COMPONENTS (E.G. HV CONVERTER BOARDASSEMBLY, SENSOR SUPPORT ASSEMBLY) TO INTEGRATE THEM INTO THE HYBRID.
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