Cerene Cryotherapy Device
FDA premarket approval P180032/S020 · decided 2024-12-12
Approval details
- PMA number
- P180032
- Supplement
- S020
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cerene Cryotherapy Device
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Channel Medsystems, Inc.
- Date received
- 2024-09-19
- Decision date
- 2024-12-12
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Emeryville, CA
- Statement
- Approval for the change to sterilization methods to allow the Cerene Cryotherapy Device to be sterilized up to two times with ethylene oxide (2X EO).
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