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 | REVEAL DX. REVEAL XT, REVEAL LINQ INSERTABLE CARDIAC MONITOR |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P890003 |
Supplement Number | S305 |
Date Received | 03/18/2014 |
Decision Date | 05/16/2014 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR FIRMWARE UPDATES (VERSION CM2490G_15V6) TO THE CARELINK MONITOR MODEL 2490G CARELINK HOME MONITORS, MODEL 2020A CARDIOSIGHT READER, AND MODEL 2020B CARELINK EXPRESS FOR A VARIETY OF IMPLANTED DEVICES. |
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