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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 NameADVISA SR MRI
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
Applicant MEDTRONIC INC.
PMA NumberP980035
Supplement NumberS427
Date Received06/03/2015
Decision Date06/27/2015
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Four (4) manufacturing changes for the advisa sr mri model a3sr01 that had been previously approved for predecessor devices to align the advisa sr mri manufacturing process with the predecessor device manufacturing processes: 1) ic supplier process flow update to bicmos; 1) additional leak test station for medium rate battery; 2) additional work stations at medium rate battery supplier; and 3) final pack equipment implementation (coquilpuls line) ¿ phase ii.
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