PMA P110021S029
- Device
- EDWARD SAPIEN TRANSCATHETER HEART VALVE AND ACCESSIRUES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S029
- Product code
- NPT
- Decision date
- 2013-11-26
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- IMPLEMENTATION OF AN AUTOMATED TUBE CUTTING FIXTURE TO REPLACE MANUAL CUTTING.
Current openFDA PMA Record#
- Device
- EDWARD SAPIEN TRANSCATHETER HEART VALVE AND ACCESSIRUES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S029
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2013-11-26
- Decision code
- OK30
- Date received
- 2013-10-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF AN AUTOMATED TUBE CUTTING FIXTURE TO REPLACE MANUAL CUTTING.