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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.
 
DeviceAFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS
Generic NamePulse generator, permanent, implantable
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS158
Date Received11/16/2007
Decision Date12/14/2007
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ALTERNATE MANUFACTURING PROCESS FOR ATTACHMENT OF THE HEADER FOR THE DEVICE.
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