PMA P000007S012
- Device
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2007-01-18
- Generic name
- replacement Heart-valve
- Approval order statement
- APPROVAL FOR CHANGING THE NUMBER OF TURNS PER METER TO THE SEWING THREAD.
Current openFDA PMA Record
- Device
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P000007
- Supplement
- S012
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2007-01-18
- Decision code
- APPR
- Date received
- 2006-09-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGING THE NUMBER OF TURNS PER METER TO THE SEWING THREAD.