PMA P200015S023
- Device
- Edwards SAPIEN 3 Pulmonic Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S023
- Product code
- NPV
- Decision date
- 2022-07-25
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- Addition of an optional manufacturing aid for the SAPIEN 3 Pulmonic Delivery System balloon component.
Current openFDA PMA Record#
- Device
- Edwards SAPIEN 3 Pulmonic Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S023
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2022-07-25
- Decision code
- OK30
- Date received
- 2022-06-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an optional manufacturing aid for the SAPIEN 3 Pulmonic Delivery System balloon component.