Cerene Cryotherapy Device
FDA premarket approval P180032/S001 · decided 2020-07-08
Approval details
- PMA number
- P180032
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Cerene Cryotherapy Device
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Channel Medsystems, Inc.
- Date received
- 2020-01-03
- Decision date
- 2020-07-08
- Days to decision
- 187 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Emeryville, CA
- Statement
- Approval for changes to the specifications of the device including the upper limit of the amount of N2O delivered, the operating temperature range, and the parameter range of initiating a fault, as well as changes to LCD prompts, the venting mechanism, hardware, tray packaging, software, and contractors for sterilizing, packaging, and labeling.
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