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 | MEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS |
Generic Name | Programmer, pacemaker |
Regulation Number | 870.3700 |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P890003 |
Supplement Number | S253 |
Date Received | 07/05/2012 |
Decision Date | 01/29/2013 |
Product Code |
KRG |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE VIVA/BRAVA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION (CRT-D). |
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