PMA
P950029: CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER
FDA PMA · Implantable pacemaker Pulse-generator · MicroPort CRM S.r.l.
Key facts
| PMA number | P950029 |
|---|---|
| Trade name | CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | MicroPort CRM S.r.l. |
| Owner/operator | MicroPort CRM S.R.L. |
| Product code | DXY |
| Approval date | Mar 10, 1997 |
| Docket number | 97M-0185 |
| Notice date | May 19, 1997 |
| Establishment registration | 1000165971 |
| FEI number | 1000165971 |
At a glance
- 100–999 Supplements
- Jul 23, 2025 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: