FDA.reportPublic FDA data

PMA P140013S011

Device
Minerva Endometrial Ablation System
Applicant
Axora Medical, Inc.
PMA number
P140013
Supplement
S011
Product code
MNB
Decision date
2020-02-12
Generic name
Device, thermal ablation, endometrial
Approval order statement
Approval for a manufacturing site change to your new facility located at Minerva Surgical, 4255 Burton Drive, Santa Clara, California.  The facility operations at this site involve the manufacturing of the Minerva Endometrial Ablation System Disposable Handpiece.

Current openFDA PMA Record#

Device
Minerva Endometrial Ablation System
Applicant
Axora Medical, Inc.
PMA number
P140013
Supplement
S011
Product code
MNB
Generic name
Device, thermal ablation, endometrial
Decision date
2020-02-12
Decision code
APPR
Date received
2020-01-13
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 Minerva Surgical, 4255 Burton Drive, Santa Clara, California.  The facility operations at this site involve the manufacturing of the Minerva Endometrial Ablation System Disposable Handpiece.