NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

FDA premarket approval P010013/S041 · decided 2013-02-01

Approval details

PMA number

P010013

Supplement

S041

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Generic name

Device, thermal ablation, endometrial

Applicant

Hologic, Inc.

Date received

2011-09-07

Decision date

2013-02-01

Days to decision

513 days

Decision code

APPR

Product code

MNB

Advisory committee

Obstetrics/Gynecology

Expedited review

No

Location

Malborough, MA

Statement

APPROVAL OF LABELING CHANGES PERTAINING TO THE USE OF NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION IN PATIENTS WHO HAVE MICRO-INSERTS FROM THE ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL TRAILING INTO THE ENDOMETRIAL CAVITY FROM THE FALLOPIAN TUBES.

510(k) clearances by this applicant