|Trade Name||SUBCURANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for adding language in the implant manuals of the referenced devices which states and clarifies that good tissue contact with the electrode and pulse generator is important for optimizing sensing and therapy delivery.