| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | MEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS |
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| Classification Name | programmer, pacemaker |
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| Generic Name | implantable pulse generator |
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| Regulation Number | 870.3700 |
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| Applicant | MEDTRONIC INC. |
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| PMA Number | P890003 |
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| Supplement Number | S253 |
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| Date Received | 07/05/2012 |
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| Decision Date | 01/29/2013 |
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| Product Code | |
| Advisory Committee |
Cardiovascular |
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| Clinical Trials |
NCT00980057
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| Supplement Type | normal 180 day track |
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| Supplement Reason | change design/components/specifications - component |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for the viva/brava implantable cardioverter defibrillators with cardiac resynchronization (crt-d). |
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