PMA P000007S006
- Device
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2005-02-28
- Generic name
- replacement Heart-valve
- Approval order statement
- ADDITION OF AN ADDITIONAL SEMI-AUTOMATIC TORQUE MACHINE AND ASSOCIATED TOOLING.
Current openFDA PMA Record
- Device
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P000007
- Supplement
- S006
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2005-02-28
- Decision code
- OK30
- Date received
- 2005-01-31
- Supplement type
- 30-Day Notice
- Approval order statement
- ADDITION OF AN ADDITIONAL SEMI-AUTOMATIC TORQUE MACHINE AND ASSOCIATED TOOLING.