|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||SUREFIX TM MODEL 5072 LEAD|
|Classification Name||permanent pacemaker electrode|
|Generic Name||pacing lead|
|Applicant||MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT|
|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.