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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.
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
PMA NumberP980035
Supplement NumberS233
Date Received06/29/2011
Decision Date07/28/2011
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Five changes to gen2 hybrid tester final test solution: 1) update to the force measure_ngt2 module; 2) update the pulse amplitude and pulse width test , pulse amplitude 7500 mv and amplitude 7500 mv test sequences; 3) widen the tolerance of the stability check criteria for the pulse amplitude and pulse width test ;4) update the configuration settings for the pulse amplitude 7500 mv and unipolar bipolar switch test and the inter-chamber crosstalk test; and 5) update the electrically erasable programmable read only memory (eeprom) cyclic redundancy check (crc).