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/DR-T/VR-VR-T LEXOS DR/DR-T/VR-VR-T; LUMOS DR-T/VR-T; XELOS DR-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 | S064 |
Date Received | 12/16/2015 |
Decision Date | 04/13/2016 |
Product Codes |
NIK NVZ NKE LWS |
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 PSW 1506.U Programmer Software. |
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