PMA
P900022: CHORUS DDD PACEMAKER
FDA PMA · Implantable pulse generator, pacemaker (non-CRT) · MicroPort CRM S.r.l.
Key facts
| PMA number | P900022 |
|---|---|
| Trade name | CHORUS DDD PACEMAKER |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | MicroPort CRM S.r.l. |
| Owner/operator | MicroPort CRM USA, Inc. |
| Product code | LWP |
| Approval date | Sep 6, 1991 |
| Docket number | 91M-0367 |
| Notice date | Oct 31, 1991 |
| Establishment registration | 3009660953 |
| FEI number | 3009660953 |
At a glance
- 10–99 Supplements
- Feb 4, 2009 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: