PMA P110021S035
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S035
- Product code
- NPT
- Decision date
- 2014-03-10
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- CHANGE TO THE MANUFACTURING PROCESS OF THE CRIMPER COMPONENT FOR THE 26 MM DEVICE SIZE.
Current openFDA PMA Record#
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S035
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2014-03-10
- Decision code
- OK30
- Date received
- 2014-02-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE MANUFACTURING PROCESS OF THE CRIMPER COMPONENT FOR THE 26 MM DEVICE SIZE.