|
Device | CareLink SmartSync Azure Astra App and Azure Astra DR/SR/XT MRI SureScan IPGs |
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 | S536 |
Date Received | 02/12/2018 |
Decision Date | 02/28/2019 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for changes to the Medtronic CareLink SmartSync Device Manager and an additional application intended to be used for programming Azure and Astra implantable devices |