Cerene® Cryotherapy Device
FDA premarket approval P180032/S005 · decided 2021-04-27
Approval details
- PMA number
- P180032
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Cerene® Cryotherapy Device
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Channel Medsystems, Inc.
- Date received
- 2021-03-29
- Decision date
- 2021-04-27
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Emeryville, CA
- Statement
- Approval for the addition of additional adverse event information and clarification of troubleshooting instructions to the labeling of the instructions for use (IFU-3243 Rev E).
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