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 | ILESTO ICD'S AND CRT-D'S |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P050023 |
Supplement Number | S074 |
Date Received | 11/25/2013 |
Decision Date | 05/04/2014 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01761162
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Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR MRI-CONDITIONAL LABELING FOR THE ENTOVIS SR / SR-T / DR / DR-T PACEMAKERS, AND THE SUPPORTING PROGRAMMER SOFTWARE VERSION PSW 1307.U. WHEN AN ENTOVIS PACEMAKER IS USED IN CONJUNCTION WITH SETROX S 53/60 OR SAFIO 53/60 PACEMAKER LEADS IT SHALL BEIDENTIFIED AS THE ENTOVIS PROMRI SYSTEM. |
Approval Order | Approval Order |
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