PMA P010041S050
- Device
- CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROTHESIS
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2014-05-19
- Generic name
- replacement Heart-valve
- Approval order statement
- APPROVAL FOR UPGRADING THE PRINTED CIRCUIT BOARD (PCB) OF THESENSITECH AGALERT® TEMPERATURE INDICATOR WITH MINOR HARDWARE ENHANCEMENTS.
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P010041
- Supplement
- S050
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2014-05-19
- Decision code
- APPR
- Date received
- 2014-03-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR UPGRADING THE PRINTED CIRCUIT BOARD (PCB) OF THESENSITECH AGALERT® TEMPERATURE INDICATOR WITH MINOR HARDWARE ENHANCEMENTS.