PMA
P870025: FETAL ACOUSTIC STIMULATOR, MODEL 0146AAY
FDA PMA · Stimulator, fetal, acoustic · Ge Medical Systems, Inc.
Key facts
| PMA number | P870025 |
|---|---|
| Trade name | FETAL ACOUSTIC STIMULATOR, MODEL 0146AAY |
| Generic name | Stimulator, fetal, acoustic |
| Applicant | Ge Medical Systems, Inc. |
| Owner/operator | GE HealthCare Technologies Inc. |
| Product code | MCP |
| Approval date | Aug 31, 1988 |
| Docket number | 88M-0346 |
| Notice date | Nov 30, 1988 |
| Establishment registration | 2126677 |
| FEI number | 2126677 |
At a glance
- 10–99 Supplements
- Oct 10, 2012 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- Yes Withdrawn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: