Cerene Cryotherapy Device
FDA premarket approval P180032/S006 · decided 2021-08-27
Approval details
- PMA number
- P180032
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Cerene Cryotherapy Device
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Channel Medsystems, Inc.
- Date received
- 2021-06-30
- Decision date
- 2021-08-27
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Emeryville, CA
- Statement
- Approval for a design change to the Inflow Solenoid, miniature solenoid valve, and miniature solenoid valve gasket.
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