PMA P200015S001
- Device
- Edwards SAPIEN 3 Transcatheter Heart Valve (Pulmonic)
- Applicant
- Edwards Lifesciences, LLC
- Product code
- NPV
- Decision date
- 2020-11-10
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- Modifications to the Solutions Mixing Clean Room in the Singapore facility.
Current openFDA PMA Record#
- Device
- Edwards SAPIEN 3 Transcatheter Heart Valve (Pulmonic)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S001
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2020-11-10
- Decision code
- OK30
- Date received
- 2020-10-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the Solutions Mixing Clean Room in the Singapore facility.