PMA supplement
P950029 S127: ALIZEA SR/DR and CELEA SR/DR 1.5T and 3T Full Body MRI conditional pacemakers
FDA PMA supplement · Normal 180 Day Track · MicroPort CRM S.r.l.
Key facts
| Original PMA | P950029 |
|---|---|
| Supplement number | S127 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ALIZEA SR/DR and CELEA SR/DR 1.5T and 3T Full Body MRI conditional pacemakers |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | MicroPort CRM S.r.l. |
| Product code | DXY |
| Received date | Aug 10, 2020 |
| Decision date | May 17, 2023 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: