Cerene Cryotherapy Device (Model Number FGS-7000)
FDA premarket approval P180032/S016 · decided 2024-04-11
Approval details
- PMA number
- P180032
- Supplement
- S016
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Cerene Cryotherapy Device (Model Number FGS-7000)
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Channel Medsystems, Inc.
- Date received
- 2024-03-15
- Decision date
- 2024-04-11
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Emeryville, CA
- Statement
- approval for labeling changes to address an error code that may occur during device use.
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