PMA P000040

Device: Genesys HTA System
Applicant: Axora Medical, Inc.
PMA number: P000040
Supplement: S042
Product code: MNB
Decision date: 2022-05-26
Generic name: Device, thermal ablation, endometrial
Approval order 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.

Current openFDA PMA Record#

Device: Genesys HTA System
Applicant: Axora Medical, Inc.
PMA number: P000040
Supplement: S042
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2022-05-26
Decision code: APPR
Date received: 2022-04-27
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.