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 MRI XT DR SureScan ICD DDMB1D1, Evera MRI XT VR SureScan ICD DVMB1D1, Evera MRI S DR SureScan ICD DDMC3D1, Evera M
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: Medtronic Cardiac Rhythm Disease Management; 8200 Coral Sea St. N.E; Ms Mvs11; Mounds View, MN 55112
• PMA Number: P980016
• Supplement Number: S607
• Date Received: 10/19/2016
• Decision Date: 11/14/2016
• 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: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Various previously accepted changes to align manufacturing of the Evera MRI and Visia AF DF-1 ICD device models with existing manufacturing, including, 1) Changes to the integrated circuit wafer manufacturing process; 2) an update to the distribution control sorter tool system; 3) updates to the post sterilization test; 4) a change to the suppliers cleaning process for the accelerometer; 5) changes to the wafer manufacturing process; 6) an update to the manufacturing inspection process for feedthrough assemblies; and 7) to update to the manufacturing execution system to FACTORYworks 9.2 at the Medtronic Tempe Campus.