PMA supplement
P060027 S083: Platinium, Paradym RF, RF VR, RF DR, Intensia CRT-Ds
FDA PMA supplement · Real-Time Process · MicroPort CRM S.r.l.
Key facts
| Original PMA | P060027 |
|---|---|
| Supplement number | S083 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Platinium, Paradym RF, RF VR, RF DR, Intensia CRT-Ds |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | MicroPort CRM S.r.l. |
| Product code | DXY |
| Received date | Jul 21, 2016 |
| Decision date | Sep 27, 2016 |
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: