PMA P110021S010
- Device
- Edwards Sapien Transcatheter Heart Valve
- Applicant
- EDWARDS LIFESCIENCES LLC.
- PMA number
- P110021
- Supplement
- S010
- Decision date
- 2013-04-18
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S010
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2013-04-18
- Decision code
- APPR
- Date received
- 2013-03-28
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR IMPLEMENTATION OF MORE DETAILED CRIMPER MANUFACTURING INSTRUCTIONS AND ADDITIONAL QUALITY CONTROL STEPS TO ENHANCE THE SAFETY OF THE CRIMPER DEVICES.