Premarket Approval (PMA)

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.

• Device: EVERA S DR, EVERA S VR, EVERA XT DR
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT; 8200 CORAL SEA STREET N.E.; MS MVS11; MOUNDS VIEW, MN 55112
• PMA Number: P980016
• Supplement Number: S408
• Date Received: 04/08/2013
• Decision Date: 05/03/2013
• Product Code: LWS
• 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  
ADDITION OF A SPECIFIC ACCEPTANCE CRITERION TO ALLOW DELAMINATION FOR THE LOWER WIRE BONDPAD ON THE U31 FET; 2) TWO PROCESS ADJUSTMENT CHANGES FOR THE INTEGRATED CIRCUIT AT MEDTRONIC SUPPLIER3) THE IMPLEMENTATION OF ADDITIONAL TOOLING FOR THE CASE LINER ASSEMBLY MANUFACTURINGPROCESS; 4) A CHANGE TO THE HYBRID CD SURGE MANUFACTURING TEST SOFTWARE; 5) THREE CHANGES INCLUDING THE IMPLEMENTATION OF A BURN-IN OVEN FOR THE RECOVERY AND FINAL VOLTAGE MEASUREMENTS STEPS FOR THE BATTERIES OF THE SUBJECT DEVICES, CORRECTIONS TO THESUBJECT SYSTEMS' BATTERY TEST SPECIFICATION TO ALIGN WITH MEASUREMENT SYSTEM CAPABILITIES,AND CONSOLIDATION OF MEASUREMENT STEPS WITHIN THE BURN IN TEST PROCESS; AND6) THE IMPLEMENTATION OF ADDITIONAL LASER WELDERS TO INCREASE MANUFACTURING CAPACITY.