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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.
 
DeviceCADENCE FAMILY ICDS
Generic NamePulse generator, permanent, implantable
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS206
Date Received04/02/2009
Decision Date05/07/2009
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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