PMA P110021S047
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S047
- Product code
- NPT
- Decision date
- 2014-11-14
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- NEW ENCLOSURE AND EQUIPMENT TO BE USED IN THE PARTICULATE EVALUATION PROCESS OF COMPONENTS.
Current openFDA PMA Record#
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S047
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2014-11-14
- Decision code
- OK30
- Date received
- 2014-10-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- NEW ENCLOSURE AND EQUIPMENT TO BE USED IN THE PARTICULATE EVALUATION PROCESS OF COMPONENTS.