PMA supplement
P950029 S114: Reply SR, Reply Dr, Esprit SR, Esprit DR (2nd generation, i.e. V2) & (5TH generation i.e.V5)
FDA PMA supplement · 30-Day Notice · MicroPort CRM S.r.l.
Key facts
| Original PMA | P950029 |
|---|---|
| Supplement number | S114 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Reply SR, Reply Dr, Esprit SR, Esprit DR (2nd generation , i.e. V2 ) & (5TH generation i.e.V5) |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | MicroPort CRM S.r.l. |
| Product code | DXY |
| Received date | Jul 7, 2017 |
| Decision date | Aug 3, 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: