PMA
P020031: MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM
FDA PMA · Device, thermal ablation, endometrial · Microsulis Medical, Ltd.
Key facts
| PMA number | P020031 |
|---|---|
| Trade name | MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM |
| Generic name | Device, thermal ablation, endometrial |
| Applicant | Microsulis Medical , Ltd. |
| Product code | MNB |
| Approval date | Sep 23, 2003 |
| Docket number | 04M-0031 |
| Notice date | Jan 22, 2004 |
| FEI number | 3003225702 |
At a glance
- 1–9 Supplements
- Sep 2, 2008 Latest supplement decision
- Yes Withdrawn
- Yes 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: