PMA supplement
P980049 S123: PLATINIUM VR 1210, 1240; DR 1510, 1540, CRT-D 1711, 1741
FDA PMA supplement · Normal 180 Day Track · MicroPort CRM S.r.l.
Key facts
| Original PMA | P980049 |
|---|---|
| Supplement number | S123 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | PLATINIUM VR 1210, 1240; DR 1510, 1540, CRT-D 1711, 1741 |
| Generic name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
| Applicant | MicroPort CRM S.r.l. |
| Product code | MRM |
| Received date | Dec 19, 2016 |
| Decision date | Oct 26, 2017 |
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: