FDA.reportPublic FDA data

PMA P010013S083

Device
NovaSure Impedance Controlled Endometrial Ablation System
Applicant
Hologic, Inc.
PMA number
P010013
Supplement
S083
Product code
MNB
Decision date
2021-03-30
Generic name
Device, thermal ablation, endometrial
Approval order statement
Consolidation of inspection test steps to reduce any over-manipulation of the devices in the manufacturing process and modification of the current inspection sampling method for the Array Liner and Array Sewing Assembly of the NovaSure Gen 4.1 devices from a defined sampling size to a credit sampling method.

Current openFDA PMA Record#

Device
NovaSure Impedance Controlled Endometrial Ablation System
Applicant
Hologic, Inc.
PMA number
P010013
Supplement
S083
Product code
MNB
Generic name
Device, thermal ablation, endometrial
Decision date
2021-03-30
Decision code
OK30
Date received
2021-03-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Consolidation of inspection test steps to reduce any over-manipulation of the devices in the manufacturing process and modification of the current inspection sampling method for the Array Liner and Array Sewing Assembly of the NovaSure Gen 4.1 devices from a defined sampling size to a credit sampling method.