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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameVITALITY HE, RENEWAL 3 AND RENEWAL 3RF FAMILIES OF ICDS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepulse generator
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS117
Date Received03/06/2006
Decision Date04/05/2006
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updates to the specifications of the devices regarding confirmation of meeting hermetic and arc suppression under high voltage requirements related to the atmospheric gas within the device.
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