PMA P010013S071

Device
NovaSure Impedance Controlled Endometrial Ablation System
Applicant
Hologic, Inc.
PMA number
P010013
Supplement
S071
Product code
MNB
Decision date
2018-07-25
Classification
Device, Thermal Ablation, Endometrial
Generic name
Device, thermal ablation, endometrial
Approval order statement
Addition of a supplier.

Current openFDA PMA Record#

Device
NovaSure Impedance Controlled Endometrial Ablation System
Applicant
Hologic, Inc.
PMA number
P010013
Supplement
S071
Product code
MNB
Generic name
Device, thermal ablation, endometrial
Decision date
2018-07-25
Decision code
OK30
Date received
2018-06-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a supplier.