FLUENCY PLUS ENDOVASCULAR STENT GRAFT
FDA premarket approval P130029 · decided 2014-06-17
Approval details
- PMA number
- P130029
- Trade name
- FLUENCY PLUS ENDOVASCULAR STENT GRAFT
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2013-12-17
- Decision date
- 2014-06-17
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR THE FLUENCY PLUS ENDOVASCULAR STENT GRAFT. THIS DEVICE IS INDICATED FOR USE IN THE TREATMENT OF IN-STENT RESTENOSIS IN THE VENOUS OUTFLOW OF HEMODIALYSIS PATIENTS DIALYZING BY EITHER AN ARTERIOVENOUS(AV) FISTULA OR AV GRAFT.
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