Cerene Cryotherapy Device
FDA premarket approval P180032/S004 · decided 2021-02-23
Approval details
- PMA number
- P180032
- Supplement
- S004
- 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
- 2021-02-01
- Decision date
- 2021-02-23
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Emeryville, CA
- Statement
- Change in facility within the same establishment.
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