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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 ICD'S
Generic NamePulse generator, permanent, implantable
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS161
Date Received10/22/2007
Decision Date12/19/2007
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING MODIFICATIONS: 1) REPLACE THE EXISTING HAND SOLDER INTERCONNECTIONS BETWEEN SUBASSEMBLIES WITH PLUG/RECEPTACLE CONNECTORS; 2) AN ORGANIC SUBSTRATE WILL BE USED FOR THE HYBRID MODULE; AND 3) DISCRETE SURFACE MOUNT MAGNETIC COMPONENTS WERE RE-CONFIGURED INTO SURFACE-MOUNTABLE PACKAGES.
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