PMA P000007
- Device
- EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2014-05-20
- 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
- EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P000007
- Supplement
- S046
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2014-05-20
- 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.