|
Device | Aurora EV-ICD System |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Medtronic, Inc. 8200 Coral Sea Street NE MV MVS11 Mounds View, MN 55112 |
PMA Number | P220012 |
Supplement Number | S020 |
Date Received | 03/25/2024 |
Decision Date | 04/24/2024 |
Product Codes |
LWS NVY |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT06048731
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement of the revised protocol for the Enlighten post-approval study (PAS). The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220012 |