PMA P000007S010
- Device
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2600P
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2005-12-06
- Generic name
- replacement Heart-valve
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN INSPECTION FOR THE 3.8 OZ JAR USED TO PACKAGE THE BIOPROSTHETIC HEART VALVES.
Current openFDA PMA Record
- Device
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2600P
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P000007
- Supplement
- S010
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2005-12-06
- Decision code
- APPR
- Date received
- 2005-11-14
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN INSPECTION FOR THE 3.8 OZ JAR USED TO PACKAGE THE BIOPROSTHETIC HEART VALVES.