PMA P110021S017
- Device
- Edwards Sapien Transcatheter Heart Valve And Trans
- Applicant
- EDWARDS LIFESCIENCES LLC.
- PMA number
- P110021
- Supplement
- S017
- Decision date
- 2013-07-03
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S017
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2013-07-03
- Decision code
- OK30
- Date received
- 2013-06-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- THREE NEW FIXTURES USED IN THE MANUFACTURING PROCESS, REMOVAL OF A DEBURR MANDREL TOOL, AND ADDITIONAL INSPECTIONS ASSOCIATED WITH THESE CHANGES.