Pulmonary Valve SG
The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human tissue.
CryoValve® SG Pulmonary Human Heart Valve - SGPV10
A non-sterile, implantable, allograft heart valve obtained from a human cadaver intended to be used to repair or replace a dysfunctional native or prosthetic heart valve in a patient. It is aseptically processed and treated to render the tissue decellularized. The device is typically used to treat acquired or congenital valvular disease and not intended to be sterilized prior to use.
- At or Below -135 degrees Celsius
- Internal Diameter: Ranges from 6mm to 32mm (allograft specific)
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Device Name: Heart Valve, More Than Minimally Manipulated Allograft
Device Class: U
Physical State: The allograft heart valve has been more than minimally manipulated.
Definition: For the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary heart valves. They may also be used in the replacement of native pulmonary heart valves when the ross procedure is performed. Pulmonary heart valve allografts are used to repair both congential and acquired valvular lesions.
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: The allograft heart valve replaces the native or prosthetic pulmonary heart valve.
Life Sustain Support Flag: N
Unclassified Reason: 1
Implant Flag: Y
Target Area: pulmonary heart valve
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/ADevice Identifiers
Device Id: 00877234000454
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