|
Device | 4598MEDTRONIC ATTAIN ABILITY MODEL 4196, ATTAIN PERFORMA S MRI SURESCAN LEAD MODEL |
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 | S107 |
Date Received | 01/25/2017 |
Decision Date | 04/25/2017 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for 1.5 and 3T MR Conditional labeling for MRI SureScan Lead Model 6946M. |