|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||RES-Q(TM) MICRON ICD SYSTEM|
|Applicant||SULZER INTERMEDICS, INC.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a design change to the is-1 connector of the existing defibrillation/pacing leads.