|
Device | Attain Ability MRI / Plus / Straight SureScan Leads; Attain Performa MRI / Straight / S MRI SureScan Leads |
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 | S101 |
Date Received | 11/02/2016 |
Decision Date | 04/25/2017 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval of 1.5 and 3T MR Conditional Labeling for SelectSecure MRI SureScan Lead Model 3830. |