|
Device | Emblem S-ICD Electrode Delivery System (model 4712) |
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 | S102 |
Date Received | 12/19/2017 |
Decision Date | 04/19/2018 |
Product Code |
LWS |
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 a new S-ICD kit of tunneling tools, called EMBLEM S-ICD Electrode Delivery System (EDS), Model 4712. |