|
Device | PACEMAKER ICD CRT NON IMPLANTED COMPONENTS |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P050023 |
Supplement Number | S105 |
Date Received | 12/07/2016 |
Decision Date | 05/04/2017 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02290028
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Sentus ProMRI OTW QP L/S family of left ventricular pacing leads. |
Post-Approval Study | Show Report Schedule and Study Progress |