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. |
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Device | ADVISA SR MRI |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S419 |
Date Received | 03/24/2015 |
Decision Date | 04/21/2015 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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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