PMA
P180032: Cerene® Cryotherapy Device
FDA PMA · Device, thermal ablation, endometrial · Channel Medsystems, Inc.
Key facts
| PMA number | P180032 |
|---|---|
| Trade name | Cerene® Cryotherapy Device |
| Generic name | Device, thermal ablation, endometrial |
| Applicant | Channel Medsystems, Inc. |
| Owner/operator | Channel Medsystems |
| Product code | MNB |
| Approval date | Mar 28, 2019 |
| Docket number | 19M-1506 |
| Notice date | Mar 29, 2019 |
| Establishment registration | 3012018285 |
| FEI number | 3012018285 |
At a glance
- 10–99 Supplements
- Sep 15, 2026 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- No Withdrawn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: