PMA
P850051: ACTIVITRAX MODELS 8400, 8402, 8403
FDA PMA · Pulse-generator, single chamber, sensor driven, implantable · Medtronic, Inc.
Key facts
| PMA number | P850051 |
|---|---|
| Trade name | ACTIVITRAX MODELS 8400, 8402, 8403 |
| Generic name | Pulse-generator, single chamber, sensor driven, implantable |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | LWO |
| Approval date | Jun 10, 1986 |
| Docket number | 86M-0266 |
| Notice date | Jul 11, 1986 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 10–99 Supplements
- Mar 20, 2025 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- No Withdrawn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: