|
Device | BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S440 |
Date Received | 03/28/2014 |
Decision Date | 05/23/2014 |
Product Code |
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 CHANGES OF THE DEFORMATION ELEMENT (DE) IN THE HIGH VOLTAGE CAPACITOR ELECTRICAL FEEDTHROUGH FOR THE DEVICES. |