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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 Nameimplantable pulse generator
PMA NumberP980035
Supplement NumberS418
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 
Fourteen (14) 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) tooling changes and alternate supplier for ft insulator; 2) manufacturing process change for printed wiring board substrates; 3) leak check tester with software updates; 4) new material supplier and specification update for p(etfe); 5) plasma cleaning process change; 6) factoryworks release 7. 11; and 7) space data collector tracking system update at nikon rout; 8) update to final assembly processing temperature requirements 9) universal burn in test system (ubits) software update; 10) modify in-process battery inspection requirements; 11) vision system implementation at mjc sterilization area; 12) vision system for connector and radiopaque verification at smo; 13) ic die sorter equipment software configuration update; and 14) final visual criteria change.