CNDT 200H12 CONTEGRA GBR1 HDE TEMP IND

CNDT 200H12 CONTEGRA GBR1 HDE TEMP IND
Contegra® - 200H12

A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair/replace a dysfunctional pulmonary heart valve, or to replace a pulmonary valve in patients undergoing a pulmonary autograft (Ross) procedure. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.

• Valve Size 12 MM

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MWH

Device Name: Pulmonic Valved Conduit

Device Class: f

Physical State: N/A

Definition: N/A

Submission Type ID: 6

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00643169298644

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