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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 OF ICDS
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS264
Date Received05/02/2011
Decision Date08/03/2011
Product Codes LWP LWS NIK NKE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR MODEL 3330 PROGRAMMER SOFTWARE VERSION 10.1.2, WHICH INCLUDES MINOR MODIFICATIONS TO THE PACING LEAD IMPEDANCE FEATURE.
Approval OrderApproval Order
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