|
Device | CareLink SmartSync Viva Brava Evera Application, CareLink SmartSync Claria Amplia Compia Application |
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 | S796 |
Date Received | 07/25/2022 |
Decision Date | 10/06/2022 |
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 new SmartSync software applications to provide support for additional families of market-released CIEDs. |