PMA P000007S003
- Device
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2003-05-09
- Generic name
- replacement Heart-valve
- Approval order statement
- APPROVAL FOR THE REPLACEMENT OF THE PACKAGE TEMPERATURE INDICATOR TO THE TAGALERT ELECTRONIC TEMPERATURE INDICATOR (HIGH AND LOW).
Current openFDA PMA Record
- Device
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P000007
- Supplement
- S003
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2003-05-09
- Decision code
- APPR
- Date received
- 2002-11-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE REPLACEMENT OF THE PACKAGE TEMPERATURE INDICATOR TO THE TAGALERT ELECTRONIC TEMPERATURE INDICATOR (HIGH AND LOW).