PMA P000007S014
- Device
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2008-12-12
- Generic name
- replacement Heart-valve
- Approval order statement
- APPROVAL FOR UPDATED LABELING BASED ON THE POST APPROVAL STUDY.
Current openFDA PMA Record
- Device
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P000007
- Supplement
- S014
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2008-12-12
- Decision code
- APPR
- Date received
- 2008-01-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR UPDATED LABELING BASED ON THE POST APPROVAL STUDY.