PMA P010041S011
- Device
- CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2007-01-29
- Generic name
- replacement Heart-valve
- Approval order statement
- APPROVAL FOR AN ADDITIONAL SUPPLIER OF TWIST POLYTETRAFLUOROETH-YLENE (PTFE) SEWING THREAD.
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P010041
- Supplement
- S011
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2007-01-29
- Decision code
- APPR
- Date received
- 2006-08-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ADDITIONAL SUPPLIER OF TWIST POLYTETRAFLUOROETH-YLENE (PTFE) SEWING THREAD.