|
Device | BRAVA;BRAVA QUAD; CONCERTO II;CONSULTA;MAXIMO II;PROTECTA;PROTECTA XT;VIVA QUAD S;VIVA QUAD XT;VIVA S;VIVA XT CRT-DS |
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 | S526 |
Date Received | 01/11/2016 |
Decision Date | 03/10/2016 |
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 the addition of a passivation layer to the XD429 MOSFET used in the hybrid charging circuit and changes in the manufacturing process of the XD429 |