The NovaSure® Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.

The NovaSure® Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre
NovaSure SureSound - 2007

A combined handpiece and bipolar electrode array intended to be introduced into the uterine cavity to deliver radio-frequency (RF) current for coagulation/ablation of the endometrium to treat menorrhagia. It is designed to be inserted without imaging whereby the electrode array is expanded in situ to achieve full endometrium contact. It includes tubing for delivery of carbon dioxide (CO2) to assess uterine cavity integrity (intactness), and for suction to clear and maintain endometrium contact within the cavity; ablation is automatically interrupted at a pre-set impedance threshold. This is a single-use device.

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No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MNB

Device Name: Device, Thermal Ablation, Endometrial

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

Review Panel: OB

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 15420045501133

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 25420045501130

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15420045501133

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: BOX

Device Id: 35420045501137

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 25420045501130

Package Quantity: 3

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CARTON

Device Id: 45420045501134

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15420045501133

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: BOX