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: Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve
• 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: S799
• Date Received: 11/19/2021
• Decision Date: 12/17/2021
• 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

Approval Order Statement  
Add a new inspection method to the capacitor manufacturing process for ICDs and CRT-Ds.