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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.
 
DeviceADVISA SR MRI
Generic NamePulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP980035
Supplement NumberS418
Date Received03/24/2015
Decision Date04/21/2015
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  
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; AND7) 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.
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