|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||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new implantable cardioverter defibrillator (icd) system. The device, as modified, will be marketed under the trade name res-q(tm) micron model 101-09 and mdoel 101-05.