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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.
 
DeviceIDENTIFY, VERITY, VICTORY, ZEPHYR, ACCENT FAMILY OF PACEMAKER DEVICES
Generic NamePulse generator, permanent, implantable
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS231
Date Received12/11/2012
Decision Date04/23/2013
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE USE OF A SECOND SOURCE SUPPLIER FOR ANCHORS USED IN THE FIRMS ICD, CRT-D, PACEMAKER, AND CRT-P DEVICES.
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