|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||MODEL 7271 ICD|
|Generic Name||dual chamber implantable cardioverter defibrillator system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site located at medtronic, inc. , med rel, road 909, km 0. 4, barrio mariana, humacao, puerto rico, 00661.