PMA P100041S034
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S034
- Product code
- NPT
- Decision date
- 2013-07-22
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- REPLACING THE MOLD USED TO FORM THE SOFT TIP COMPONENT OF THE RETROFLEX 3 DELIVERY SYSTEM.
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S034
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2013-07-22
- Decision code
- OK30
- Date received
- 2013-06-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACING THE MOLD USED TO FORM THE SOFT TIP COMPONENT OF THE RETROFLEX 3 DELIVERY SYSTEM.