FDA.reportPublic FDA data

PMA P000040S041

Device
Minerva Genesys HTA Endometrial Ablation System
Applicant
Axora Medical, Inc.
PMA number
P000040
Supplement
S041
Product code
MNB
Decision date
2021-06-17
Generic name
Device, thermal ablation, endometrial
Approval order statement
Approval for a manufacturing site change to your new facility located at Apical Instruments, Inc, 2971 Spring Street, Redwood City, CA 94063. The facility operations at this site will involve the manufacturing of the Minerva Genesys HTA Controller.

Current openFDA PMA Record#

Device
Minerva Genesys HTA Endometrial Ablation System
Applicant
Axora Medical, Inc.
PMA number
P000040
Supplement
S041
Product code
MNB
Generic name
Device, thermal ablation, endometrial
Decision date
2021-06-17
Decision code
APPR
Date received
2021-05-20
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site change to your new facility located at Apical Instruments, Inc, 2971 Spring Street, Redwood City, CA 94063. The facility operations at this site will involve the manufacturing of the Minerva Genesys HTA Controller.