PMA P060002S011
- Device
- BARD FLAIR ENDOVASCULAR STENT GRAFT
- Applicant
- Bard Peripheral Vascular
- PMA number
- P060002
- Supplement
- S011
- Product code
- PFV
- Decision date
- 2010-04-16
- 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 MODIFICATIONS TO THE DEVICE INSTRUCTIONS FOR USE TO INCLUDE LANGUAGE TO IMPROVE THE SAFETY IN USE OF THE DEVICE, PREDOMINANTLY WITH RESPECT TO THE POTENTIAL FOR DEVICE MIGRATIONS.
Current openFDA PMA Record#
- Device
- BARD FLAIR ENDOVASCULAR STENT GRAFT
- Applicant
- Bard Peripheral Vascular
- PMA number
- P060002
- Supplement
- S011
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2010-04-16
- Decision code
- APPR
- Date received
- 2010-03-19
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE DEVICE INSTRUCTIONS FOR USE TO INCLUDE LANGUAGE TO IMPROVE THE SAFETY IN USE OF THE DEVICE, PREDOMINANTLY WITH RESPECT TO THE POTENTIAL FOR DEVICE MIGRATIONS.