|
Device | Assurity MRI, Endurity MRI |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P140033 |
Supplement Number | S068 |
Date Received | 04/08/2021 |
Decision Date | 08/13/2021 |
Product Codes |
LWP NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for use of two new MRI inductor component models in Assurity and Endurity MRI pacemaker devices and to add an alternate supplier of these components. |