|
Device | BRAVA CRT-D; VIVA S CRT-D; VIVA XT CRT-D |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S398 |
Date Received | 09/04/2013 |
Decision Date | 10/29/2013 |
Product Code |
NIK |
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 MINOR DESIGN CHANGE IN THE MULTILAYER CERAMIC CAPACITORS MADE BY A SECOND TIER SUPPLIER WHICH ARE USED IN THE DEVICES. |