|
Device | ENTRUST ICD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980016 |
Supplement Number | S191 |
Date Received | 03/27/2009 |
Decision Date | 06/24/2009 |
Product Code |
LWS |
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 VERSION 7.1 OF THE MODEL 9987 APPLICATION SOFTWARE WHICH RESETS THE ERI VOLTAGE THRESHOLD TO COMPENSATE FOR THE POTENTIAL PREMATURE LITHIUM DEPLETION. |