|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||VENTAK P MODEL 16OO|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change: packager|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site located at an alternate facility for sterilization, packaging and labeling at guidant puerto rico, dorado, puerto rico.