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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 NumberS419
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  
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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