Cerene Cryotherapy Device
FDA premarket approval P180032/S010 · decided 2022-05-31
Approval details
- PMA number
- P180032
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- 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
- 2022-05-02
- Decision date
- 2022-05-31
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Emeryville, CA
- Statement
- Approval for the modification to the manufacturing process for the subject device. This change is the addition of an inspection step made to the manufacturing process to verify that the control software has been successfully loaded onto the device.
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