PMA
P890063: GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM
FDA PMA · Monitor, uterine contraction, external (for use in clinic) · Matria Healthcare, Inc.
Key facts
| PMA number | P890063 |
|---|---|
| Trade name | GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM |
| Generic name | Monitor, uterine contraction, external (for use in clinic) |
| Applicant | Matria Healthcare, Inc. |
| Owner/operator | Jackson Medical Group |
| Product code | HFM |
| Approval date | Sep 12, 1990 |
| Docket number | 90M-0315 |
| Notice date | Oct 23, 1990 |
| Establishment registration | 3014150062 |
| FEI number | 3014150062 |
At a glance
- 1–9 Supplements
- Jun 16, 1995 Latest supplement decision
- No Withdrawn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: