|
Device | STRATOS LV AND LV-T PULSE GENERATORS |
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 | S008 |
Date Received | 11/17/2008 |
Decision Date | 03/31/2009 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00508391
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR: 1) COMMERCIAL DISTRIBUTION OF THE LUMAX HF-T CRT-DS AND STRATOS LV (-T) CRT-PS WITH VENTRICLE TO VENTRICLE (V-V) DELAY FEATURES; AND 2) UPDATED MODEL ICS 3000 PROGRAMMER SOFTWARE (RELEASE OF 802.U/2) TO IMPLEMENT THE V-V DELAY FEATURES AND OTHER MINOR ENHANCEMENTS. |