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 | Evera MRI, Evera, Marquis, Secura, Maximo II, Intrinsic, Protecta, Protecta XT, Virtuoso II, VIsia AF, Primo DR and VR M |
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 | S685 |
Date Received | 08/22/2018 |
Decision Date | 10/18/2018 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for updates to the remote monitoring systems for Attesta and Sphera MRI SureScan IPG devices. |
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