FLUENCY PLUS ENDOVASCULAR STENT GRAFT
FDA premarket approval P130029/S001 · decided 2016-05-16
Approval details
- PMA number
- P130029
- Supplement
- S001
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2015-04-08
- Decision date
- 2016-05-16
- Days to decision
- 404 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval of a new polytetrafluoroethylene (PTFE) resin.
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