|
Device | MEDTRONIC ATTAIN ABILITY STRAIGHT MODEL 4396 LEAD |
Generic Name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Applicant | MEDTRONIC Inc. 710 MEDTRONIC PARKWAY NE MINNEAPOLIS, MN 55432 |
PMA Number | P080006 |
Supplement Number | S081 |
Date Received | 04/30/2015 |
Decision Date | 06/29/2015 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVALTO THE POST-APPROVAL STUDY TO CLOSE ENROLLMENT OF THE MODEL 4396 PAS UPON COMPLETION OF THE INTERIM ANALYSIS, WHICH WILL BE INCLUDED WITHIN THE 54 MONTH PROGRESS REPORT. |