|
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 | S076 |
Date Received | 09/08/2022 |
Decision Date | 12/07/2022 |
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 MR Conditional labeling for IsoFlex pacing leads when combined with the Assurity MRI and Endurity MRI single and dual chamber implantable pulse generators. |