PMA P000007S016
- Device
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2500P
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2008-05-22
- Generic name
- replacement Heart-valve
- Approval order statement
- CHANGE IN SUPPLIERS FOR A POLYESTER RAW MATERIAL USED IN THE MANUFACTURE OF THE DEVICE.
Current openFDA PMA Record
- Device
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2500P
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P000007
- Supplement
- S016
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2008-05-22
- Decision code
- OK30
- Date received
- 2008-05-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN SUPPLIERS FOR A POLYESTER RAW MATERIAL USED IN THE MANUFACTURE OF THE DEVICE.