|
Device | ATTAIN PERFORMA MODEL 4298 LEFT VENTRICULAR 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 | S068 |
Date Received | 04/01/2014 |
Decision Date | 08/01/2014 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01751022
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE ATTAIN PERFORMA MODEL 4298 LEFT VENTRICULAR LEAD, INDICATED FOR CHRONIC PACING IN THE LEFT VENTRICLE VIA THE CARDIAC VEIN, WHEN USED WITH A COMPATIBLE MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY (CRT) SYSTEM. |
Post-Approval Study | Show Report Schedule and Study Progress |