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 | ENTRUST, VIRTUOSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, INSYNC MARQUIS, PROTECTA XT, DR, PROTEXTA DR, PROTEXTA XT, VR, |
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 | S433 |
Date Received | 08/12/2013 |
Decision Date | 10/15/2013 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A FIRMWARE UPDATE TO VERSION CM2490C_10V5 FOR THE MODEL 2490C CARELINK REMOTE HOME MONITOR AND FOR A FIRMWARE UPDATE TO VERSION CM2490G_14V2 FOR THE 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A CARDIOSIGHT READER, AND 2020B CARELINK EXPRESS MONITOR FOR THE DEVICES. |
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