Identity
- Trade Name
- Cerene® Cryotherapy Device FDA PMA
- Generic Name
- Device, thermal ablation, endometrial FDA PMA
Identifiers
- PMA Number
- P180032 FDA PMA
- FDA Product Code
- MNB FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Obstetrics/Gynecology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Cerene Cryotherapy Device is a thermal ablation device used for endometrial cryoablation. It is designed to treat premenopausal women with heavy menstrual bleeding due to benign causes for whom childbearing is complete. The device is intended to ablate the endometrial tissue, reducing or eliminating heavy menstrual bleeding. The Cerene Cryotherapy Device is a medical device that utilizes cryotherapy to achieve this goal.
The Cerene Cryotherapy Device is supplied as a single-use device and is intended for use in a clinical setting. It has received FDA PMA approval and complies with MDD and MDR regulations. The device is indicated for a specific patient population, namely premenopausal women with heavy menstrual bleeding due to benign causes. It is not intended for use in other patient populations or for other indications.
Frequently asked questions
What is the Cerene Cryotherapy Device used for?
The Cerene Cryotherapy Device is used for endometrial cryoablation in premenopausal women with heavy menstrual bleeding due to benign causes for whom childbearing is complete.
What type of device is the Cerene Cryotherapy Device?
The Cerene Cryotherapy Device is a thermal ablation device.
Has the Cerene Cryotherapy Device received regulatory approvals?
Yes, the Cerene Cryotherapy Device has received FDA PMA approval and complies with MDD and MDR regulations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CERENE cryotherapy device by Channel Medsystems - LinkedIn, Cerene Cryotherapy, Channel Medsystems Earns CE Mark Approval For The Cerene ..., Cerene® Treatment for Heavy Periods | TPMG OBGYN, MAUDE Adverse Event Report: CHANNEL MEDSYSTEMS ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Active |
| EUDAMED | European Union | MDD | — | Class III | Active |
| FDA PMA | United States | FDA_PMA | P180032 | Class III | Active |
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Manufacturer
- Manufacturer
- Channel Medsystems, Inc.
Sources (2)
- FDA PMA P180032 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026