|
Device | EMBLEM S-ICD Automated Screening Tool |
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 | S129 |
Date Received | 10/15/2019 |
Decision Date | 12/16/2019 |
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 the Automatic Screening Tool on the Model 3300 LATITUDE Programming System and associated changes to the existing programming system support software Multiple Application Utility and Data Manager. |