Cerene® Cryotherapy Device
FDA premarket approval P180032 · decided 2019-03-28
Approval details
- PMA number
- P180032
- Trade name
- Cerene® Cryotherapy Device
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Channel Medsystems, Inc.
- Date received
- 2018-08-13
- Decision date
- 2019-03-28
- Days to decision
- 227 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Emeryville, CA
- Statement
- Approval for the Cerene® Cryotherapy Device. This device is indicated for endometrial cryoablation in premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete.
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