FDA.reportPublic FDA data

PMA P010013S072

Device
NovaSure Impedance Controlled Endometrial Ablation System
Applicant
Hologic, Inc.
PMA number
P010013
Supplement
S072
Product code
MNB
Decision date
2019-01-09
Classification
Device, Thermal Ablation, Endometrial
Generic name
Device, thermal ablation, endometrial
Approval order statement
Approval for the addition of a second supplier for the gold-plated yarn material used in the Bipolar Electrode Mesh Array of the NovaSure Impedance Controlled Endometrial Ablation System.

Current openFDA PMA Record#

Device
NovaSure Impedance Controlled Endometrial Ablation System
Applicant
Hologic, Inc.
PMA number
P010013
Supplement
S072
Product code
MNB
Generic name
Device, thermal ablation, endometrial
Decision date
2019-01-09
Decision code
APPR
Date received
2018-08-23
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for the addition of a second supplier for the gold-plated yarn material used in the Bipolar Electrode Mesh Array of the NovaSure Impedance Controlled Endometrial Ablation System.