PMA P200015S078
- Device
- Edwards Commander Delivery System (9600LDS20; 9600LDS23; 9600LDS26; 9600LDS29)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S078
- Product code
- NPV
- Decision date
- 2026-06-30
- Classification
- Cardiovascular
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- implementation of an automated inspection spreadsheet during an incoming inspection
Current openFDA PMA Record#
- Device
- Edwards Commander Delivery System (9600LDS20; 9600LDS23; 9600LDS26; 9600LDS29)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S078
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2026-06-30
- Decision code
- OK30
- Date received
- 2026-06-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of an automated inspection spreadsheet during an incoming inspection