|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 6943 AND 6945|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Generic Name||pacer cardioverter defibrillator|
|Applicant|| MEDTRONIC INC.|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site lcoated at medtronic puerto rico, inc. , (mpri), road 149, rm. 56. 3, villalba, puerto rico 00755.