|
Device | LIVIAN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S154 |
Date Received | 08/22/2007 |
Decision Date | 02/15/2008 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
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 THE LIVIAN CRT-D DEVICES WITH CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2945, VERSION 1.01. |