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 | INSYNC,CONSULTA,AND SYNCRA FAMILIES OF IPGS |
Generic Name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P010015 |
Supplement Number | S175 |
Date Received | 08/24/2012 |
Decision Date | 09/25/2012 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490C MEDTRONIC CARELINK REMOTE HOME MONITOR, THE MODEL 2020A MEDTRONIC CARDIOSIGHT READER, AND THE MODEL 2020B CARELINK EXPRESS MONITOR. |
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