PMA P100041S013
- Device
- EDWARDS SAPIEN THRANSCATHETER HEART VALVE (THV)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S013
- Product code
- NPT
- Decision date
- 2012-08-09
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- UPGRADE TO BRAIDING EQUIPMENT AND REMOVAL OF SURFACTANT FOR A MANUFACTURING PROCESS.
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN THRANSCATHETER HEART VALVE (THV)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S013
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2012-08-09
- Decision code
- OK30
- Date received
- 2012-07-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPGRADE TO BRAIDING EQUIPMENT AND REMOVAL OF SURFACTANT FOR A MANUFACTURING PROCESS.