PMA P110021S015
- Device
- Edwards Sapien Transcatheter Heart Valve, Model 90
- Applicant
- EDWARDS LIFESCIENCES LLC.
- PMA number
- P110021
- Supplement
- S015
- Decision date
- 2013-06-25
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S015
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2013-06-25
- Decision code
- OK30
- Date received
- 2013-05-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE SILICONE GASKET MATERIAL (SUPPLIED BY SAINT GOBAIN) FOR THE 3.8 OZ.JAR CAP GASKET USED IN THE FINISHED-DEVICE PACKAGING CONTAINER FOR THE EDWARDS SAPIEN VALVE.