PMA P100041S041
- Device
- Edwards Sapien Transcatheter Heart Valve And Trans
- Applicant
- EDWARDS LIFESCIENCES, LLC.
- PMA number
- P100041
- Supplement
- S041
- Decision date
- 2014-03-28
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S041
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2014-03-28
- Decision code
- APPR
- Date received
- 2013-09-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THREE CHANGES PERTAINING TO THE CUTTING, TOLERANCES, AND MEASUREMENT OF THE CLOTH SKIRT ON THE EDWARDS SAPIEN¿ THV.