Genesys HTA System
FDA premarket approval P000040/S042 · decided 2022-05-26
Approval details
- PMA number
- P000040
- Supplement
- S042
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Genesys HTA System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2022-04-27
- Decision date
- 2022-05-26
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval for manufacturing sites located at Life Science Outsourcing, Inc, 830 Challenger Street, Brea, CA 92821 and sterilization services at STERIS Applied Sterilization Technologies, 43425 Business Park Drive, Temecula, CA 92590.
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