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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
ApplicantMEDTRONIC, INC.
PMA NumberP980035
Supplement NumberS419
Date Received03/24/2015
Decision Date04/21/2015
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 
Nine (9) manufacturing changes for advisa sr mri that had been previously reviewed and accepted to align the advisa sr mri manufacturing process with the predecessor device manufacturing processes: 1) antenna wire bond coat manufacturing standardization; 2) update to distribution center sorter tool (dcst) system; 3) new supplier for gold preform component (brazing preform for feed-through manufacturing); 4) second source supplier of anode substrates; 5) vapor degreaser cleaning back proliferation to legacy products; 6) new 3d laser marker at mjc; 7) statek crystal with pre-plated ceramic base statek crystal with pre-plated ceramic base; 8) alternative uv irradiation equipment for dieprep area; and 9) modification of m017/m019 probe test software.
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