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 | STRATOS LV-T |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P070008 |
Supplement Number | S003 |
Date Received | 06/02/2008 |
Decision Date | 06/24/2008 |
Product Code |
NKE |
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 A DIODE CHANGE IN THE STRATOS LV AND LV-T CRT-PS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STRATOS LV CRT-P AND STRATOS LV-T CRT-P AND IS INDICATED FOR TREATMENT OF BRADYCARDIA IN HEART FAILURE PATIENTS. |
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