PMA
P000040: HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM
FDA PMA · Device, thermal ablation, endometrial · Axora Medical, Inc.
Key facts
| PMA number | P000040 |
|---|---|
| Trade name | HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM |
| Generic name | Device, thermal ablation, endometrial |
| Applicant | Axora Medical, Inc. |
| Owner/operator | Minerva Surgical |
| Product code | MNB |
| Approval date | Apr 20, 2001 |
| Docket number | 01M-0578 |
| Notice date | Dec 21, 2001 |
| Establishment registration | 3011011193 |
| FEI number | 3011011193 |
At a glance
- 10–99 Supplements
- May 26, 2022 Latest supplement decision
- No Withdrawn
- Yes 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: