PMA
P780009: BYREL PROGRAMABLE PACEMAKER
FDA PMA · Implantable pulse generator, pacemaker (non-CRT) · Medtronic Cardiac Rhythm Disease Management
Key facts
| PMA number | P780009 |
|---|---|
| Trade name | BYREL PROGRAMABLE PACEMAKER |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | Medtronic Cardiac Rhythm Disease Management |
| Owner/operator | Medtronic, Inc. |
| Product code | LWP |
| Approval date | Mar 27, 1979 |
| Notice date | Aug 3, 1979 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 1–9 Supplements
- Jul 21, 1981 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None 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: