PMA P000007S009
- Device
- EDWARDS PRIMA PLUS STENTLESS BIOPROTHESIS, MODEL 2500P
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2005-10-07
- Generic name
- replacement Heart-valve
- Approval order statement
- APPROVAL FOR THE ALTERNATIVE 3.8 OZ. SIZE JAR AND THE PRE-PRINTED CARDBOARD CARTON.
Current openFDA PMA Record
- Device
- EDWARDS PRIMA PLUS STENTLESS BIOPROTHESIS, MODEL 2500P
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P000007
- Supplement
- S009
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2005-10-07
- Decision code
- APPR
- Date received
- 2005-08-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ALTERNATIVE 3.8 OZ. SIZE JAR AND THE PRE-PRINTED CARDBOARD CARTON.