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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAttesta DR MRI SureScan, L DR MRI SureScan, S DR MRI SureScan, SR MRI SureScan, Sphera DR MRI SureScan, L DR MRI SureSca
Generic NamePulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP980035
Supplement NumberS522
Date Received10/06/2017
Decision Date10/31/2017
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Implementation of the following previously accepted changes: modifications to heavy metal testing for silicone, additional vision system for inspection of final packaged devices, additional laser welder for use in manufacturing of the battery header subassembly, a change to the chemical used for the etch process for integrated circuit components, an update to the hybrid testing process, changes to the integrated circuit tests used for pacemaker devices, and an update to the software used in the final functional device tester.
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