Cerene Cryotherapy Device
FDA premarket approval P180032/S013 · decided 2023-07-17
Approval details
- PMA number
- P180032
- Supplement
- S013
- Supplement type
- 30-Day Notice
- 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
- 2023-06-27
- Decision date
- 2023-07-17
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Emeryville, CA
- Statement
- Modification to the manufacturing process for the subject device. This change is the implementation of updated manufacturing software and associated fixtures that automate some existing manual processes.
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