PMA P200015S024
- Device
- Edwards SAPIEN 3 Pulmonic Delivery System
- Applicant
- Edwards Lifesciences, LLC
- Product code
- NPV
- Decision date
- 2022-10-28
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- Approval for various dimensional changes to the hypotube component of the SAPIEN 3 Pulmonic Delivery System.
Current openFDA PMA Record#
- Device
- Edwards SAPIEN 3 Pulmonic Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S024
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2022-10-28
- Decision code
- APPR
- Date received
- 2022-08-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for various dimensional changes to the hypotube component of the SAPIEN 3 Pulmonic Delivery System.