|
Device | Assurity MRI, Endurity MRI family of Pacemakers |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P140033 |
Supplement Number | S048 |
Date Received | 10/22/2019 |
Decision Date | 05/13/2020 |
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 a design and supplier change of the moisture getter. |