|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Perform receiving and inspection activities for certain components and accessories used in the cameron health, inc. S-icd system at boston scientific corporations manufacturing facility located in st paul, minnesota.