Cerene Cryotherapy Device
FDA premarket approval P180032/S003 · decided 2021-02-25
Approval details
- PMA number
- P180032
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Cerene Cryotherapy Device
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Channel Medsystems, Inc.
- Date received
- 2020-10-29
- Decision date
- 2021-02-25
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Emeryville, CA
- Statement
- Approval for the addition of information from the post-approval study to the patient labeling and instructions for use
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