PMA
P910063: CAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM
FDA PMA · Home uterine activity monitor · Matria Healthcare, Inc.
Key facts
| PMA number | P910063 |
|---|---|
| Trade name | CAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM |
| Generic name | Home uterine activity monitor |
| Applicant | Matria Healthcare, Inc. |
| Owner/operator | Jackson Medical Group |
| Product code | LQK |
| Approval date | Sep 29, 1995 |
| Docket number | 96M-0255 |
| Notice date | Oct 18, 1996 |
| Establishment registration | 3014150062 |
| FEI number | 3014150062 |
At a glance
- None Supplements
- Sep 29, 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- No Withdrawn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: