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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.
 
DeviceELLIPSE FAMILY OF ICDS
Generic NamePulse generator, permanent, implantable
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS315
Date Received05/09/2013
Decision Date06/06/2013
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MODIFICATIONS TO THE IS-1 SPRING INSTALLATION PROCEDURE, THE ADDITION OF A VISUALINSPECTION OF THE SPRING, AND THE ADDITION OF AN INTERNAL THREADING INSPECTION.
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