PMA P060002S034
- Device
- FLAIR ENDOVASCULAR STENT GRAFT
- Applicant
- Bard Peripheral Vascular
- PMA number
- P060002
- Supplement
- S034
- Product code
- PFV
- Decision date
- 2014-08-13
- 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 UPDATED INSTRUCTIONS FOR USE (IFU) TO INCLUDE DATA FROM THE POSTAPPROVAL STUDY (RENOVA).
Current openFDA PMA Record#
- Device
- FLAIR ENDOVASCULAR STENT GRAFT
- Applicant
- Bard Peripheral Vascular
- PMA number
- P060002
- Supplement
- S034
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2014-08-13
- Decision code
- APPR
- Date received
- 2014-02-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR UPDATED INSTRUCTIONS FOR USE (IFU) TO INCLUDE DATA FROM THE POSTAPPROVAL STUDY (RENOVA).