PMA supplement
P980049 S117: Platinum VR/DR ICDS,Paradym RF VR/ RF DR CRT-Ds, Intensia VR, Intensia DR
FDA PMA supplement · Real-Time Process · MicroPort CRM S.r.l.
Key facts
| Original PMA | P980049 |
|---|---|
| Supplement number | S117 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Platinum VR/DR ICDS,Paradym RF VR/ RF DR CRT-Ds, Intensia VR, Intensia DR |
| 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: