FLUENCY PLUS ENDOVASCULAR STENT GRAFT
FDA premarket approval P130029/S002 · decided 2016-04-26
Approval details
- PMA number
- P130029
- Supplement
- S002
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2015-05-01
- Decision date
- 2016-04-26
- Days to decision
- 361 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 and for the treatment of stenosis in the venous outflow of hemodialysis patients dialyzing by an AV graft.
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