PMA P100041S028
- Device
- Edwards Sapien Transcatheter Heart Valve And Acces
- Applicant
- EDWARDS LIFESCIENCES, LLC.
- PMA number
- P100041
- Supplement
- S028
- Decision date
- 2013-06-10
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S028
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2013-06-10
- Decision code
- APPR
- Date received
- 2013-05-16
- Supplement type
- Special (Immediate Track)
- Approval order statement
- APPROVAL FOR A CHANGE IN THE STENT LENGTH SPECIFICATION AND CHANGES TO THE PRODUCT LABELING WHICH INCLUDED A CHANGE TO THE LABELED LENGTH OF THE STENT AND MINOR EDITORIAL MODIFICATIONS.