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
815012US - 815012US

An electrically-powered device intended to produce radio-frequency (RF) energy at a predetermined power (based on uterus size) for coagulation/ablation of the endometrium with a handpiece/electrode (not included) to treat menorrhagia. The RF generator is also intended to facilitate carbon dioxide (CO2) delivery from a CO2 cartridge for assessment of uterine cavity integrity (intactness), and includes a suction pump intended to facilitate constant contact between the electrode and endometrium. It is intended to monitor tissue impedance [resistance of the tissue to alternating electrical current (AC)] to automatically interrupt ablation at a pre-set impedance threshold.

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No Data Available

Device Sterile: False

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: 25420045505398

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: 15420045505391

Device Type: Unit of Use

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