PMA P000007S002
- Decision date
- 1969-12-31
Current openFDA PMA Record
- Device
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P000007
- Supplement
- S002
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2002-03-26
- Decision code
- APPR
- Date received
- 2001-07-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE SIZE 29 MM PRIMA PLUS STENTLESS BIOPROSTHESIS.