Fluency Plus Endovascular Stent Graft
FDA premarket approval P130029/S007 · decided 2017-10-05
Approval details
- PMA number
- P130029
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- 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
- 2017-04-10
- Decision date
- 2017-10-05
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval for an update to the labeling to include the 24-month data on patients enrolled in the clinical study.
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