PMA P100041S053
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S053
- Product code
- NPT
- Decision date
- 2014-05-16
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- CHANGES TO THE MANUFACTURING FIXTURES USED IN THE MANUFACTURING OF THE RETROFLEX 3 DELIVERY SYSTEM.
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S053
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2014-05-16
- Decision code
- OK30
- Date received
- 2014-04-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE MANUFACTURING FIXTURES USED IN THE MANUFACTURING OF THE RETROFLEX 3 DELIVERY SYSTEM.