Cerene® Cryotherapy Device
FDA premarket approval P180032/S014 · decided 2023-11-14
Approval details
- PMA number
- P180032
- Supplement
- S014
- 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
- 2023-09-01
- Decision date
- 2023-11-14
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Emeryville, CA
- Statement
- Approval for software changes for the air pump.
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