- Device
- EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P000007
- Supplement
- S038
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2013-06-11
- Decision code
- APPR
- Date received
- 2012-12-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE USE OF THE RE-DESIGNED AND RE-PROGRAMMED SENSITECH TAGALERT TEMPERATURE ALARM INDICATION WITH NEW ELECTROMAGNETIC INFERENCE/ELECTROMAGNETIC DISCHARGE (EMI/ESE) PROTECTION IN THE DEVICES.