PMA P060002S027
- Device
- FLAIR ENDOVASCULAR STENT GRAFT
- Applicant
- Bard Peripheral Vascular
- PMA number
- P060002
- Supplement
- S027
- Product code
- PFV
- Decision date
- 2013-01-16
- Classification
- System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Approval order statement
- APPROVAL FOR A LINE EXTENSION OF THE FLAIR® ENDOVASCULAR STENT GRAFT TO ADD A 70 MM LENGTH. IN ADDITION, THERE ARE THREE ADDITIONAL MINOR CHANGES. THESE INCLUDED: MANUFACTURING CORE MODIFICATION, DELIVERY SYSTEM FLARING MANDREL MODIFICATION, AND CHAMFER OF GUIDING TUBE MODIFICATION.
Current openFDA PMA Record#
- Device
- FLAIR ENDOVASCULAR STENT GRAFT
- Applicant
- Bard Peripheral Vascular
- PMA number
- P060002
- Supplement
- S027
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2013-01-16
- Decision code
- APPR
- Date received
- 2012-07-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A LINE EXTENSION OF THE FLAIR® ENDOVASCULAR STENT GRAFT TO ADD A 70 MM LENGTH. IN ADDITION, THERE ARE THREE ADDITIONAL MINOR CHANGES. THESE INCLUDED: MANUFACTURING CORE MODIFICATION, DELIVERY SYSTEM FLARING MANDREL MODIFICATION, AND CHAMFER OF GUIDING TUBE MODIFICATION.