PMA P260007
- Device
- Autus Size-Adjustable Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P260007
- Product code
- SJL
- Decision date
- 2026-10-01
- Classification
- Cardiovascular
- Generic name
- Heart-valve, polymeric
- Approval order statement
- Approval for AUTUS Size-Adjustable Valve: The AUTUS valve is indicated for the management of pediatric patients weighing greater than or equal to 10 kg who require surgical pulmonary valve replacement for dysfunctional native or surgically-repaired right ventricular outflow tract (RVOT), as determined by echocardiography to meet the following criteria: (1) severe pulmonary stenosis (i.e., right ventricle (RV) to pulmonary artery (PA) peak instantaneous gradient greater than or equal to 60 mmHg); (2) greater than or equal to moderate pulmonary regurgitation; or (3) greater than or equal to moderate pulmonary stenosis (i.e., RV to PA peak instantaneous gradient greater than or equal to 40 mmHg) and greater than or equal to moderate pulmonary regurgitation.
Current openFDA PMA Record#
- Device
- Autus Size-Adjustable Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P260007
- Product code
- SJL
- Generic name
- Heart-valve, polymeric
- Decision date
- 2026-10-01
- Decision code
- APPR
- Date received
- 2026-02-09
- Approval order statement
- Approval for AUTUS Size-Adjustable Valve: The AUTUS valve is indicated for the management of pediatric patients weighing greater than or equal to 10 kg who require surgical pulmonary valve replacement for dysfunctional native or surgically-repaired right ventricular outflow tract (RVOT), as determined by echocardiography to meet the following criteria: (1) severe pulmonary stenosis (i.e., right ventricle (RV) to pulmonary artery (PA) peak instantaneous gradient greater than or equal to 60 mmHg); (2) greater than or equal to moderate pulmonary regurgitation; or (3) greater than or equal to moderate pulmonary stenosis (i.e., RV to PA peak instantaneous gradient greater than or equal to 40 mmHg) and greater than or equal to moderate pulmonary regurgitation.