|
Device | EMBLEM (Subcutaneous ICD Devices) |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC CORPORATION 4100 HAMLINE AVENUE NORTH ST. PAUL, MN 55112-5798 |
PMA Number | P110042 |
Supplement Number | S119 |
Date Received | 12/03/2018 |
Decision Date | 02/22/2019 |
Product Codes |
LWS NVY |
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 changes to the Server and Communicator software updates necessary for LATITUDE NXT Release. |