- Device
- PRIMA PLUS STENTLESS BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P000007
- Supplement
- S001
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2002-02-12
- Decision code
- APPR
- Date received
- 2001-04-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL TO ADDRESS THE ISSUE OF LONG-TERM CLINICAL EFFECTIVENESS OF THE EDWARDS XENOLOGIX ANTICALCIFICATION TREATMENT AS STIPULATED IN THE FEBRUARY 27, 2001 APPROVAL ORDER.