|
Device | Attain Stability Quad MRI SureScan 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 | S129 |
Date Received | 10/26/2018 |
Decision Date | 04/10/2019 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
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 Stability Quad MRI SureScan Model 4798 left ventricular (LV) lead. |
Post-Approval Study | Show Report Schedule and Study Progress |