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 | BELOS DR-T,BELOS A+-T,LEXOS DR-T/LEXOS VR-T,XELOS DR-T,LUMOS DR-T/LUMOS VR-T |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P000009 |
Supplement Number | S054 |
Date Received | 04/03/2013 |
Decision Date | 05/08/2013 |
Product Codes |
LWS NIK NKE NVZ |
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 THE UPDATED VERSION 3.22.0 OF HOME MONITORINGSERVICE CENTER INCLUDING THE FEATURES:1) IMPLEMENTATION OF REMOTE SCHEDULING; AND2) AUTOMATIC EXPORT OF EHR DATA. |
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