|
Device | CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S677 |
Date Received | 03/01/2021 |
Decision Date | 05/27/2021 |
Product Code |
NVZ |
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 cardiovascular implantable electronic device (CIED) software applications on the CareLink SmartSync Device Manager. |