FLAIR ENDOVASCULAR STENT GRAFT
FDA premarket approval P060002/S027 · decided 2013-01-16
Approval details
- PMA number
- P060002
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FLAIR ENDOVASCULAR STENT GRAFT
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Applicant
- Bard Peripheral Vascular
- Date received
- 2012-07-19
- Decision date
- 2013-01-16
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR A LINE EXTENSION OF THE FLAIR® ENDOVASCULAR STENT GRAFT TO ADD A 70 MM LENGTH. IN ADDITION, THERE ARE THREE ADDITIONAL MINOR CHANGES. THESE INCLUDED: MANUFACTURING CORE MODIFICATION, DELIVERY SYSTEM FLARING MANDREL MODIFICATION, AND CHAMFER OF GUIDING TUBE MODIFICATION.
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510(k) clearances by this applicant
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| BD Trek Powered Bone Biopsy System (K213896) | Bard Peripheral Vascular | 2022-03-30 |
| EleVation Breast Biopsy System (K211933) | Bard Peripheral Vascular | 2021-07-15 |
| MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F (K062887) | Bard Peripheral Vascular | 2006-10-26 |
| FLUENCY TRACHEOBRONCHIAL STENT GRAFT (K031041) | Bard Peripheral Vascular | 2003-06-19 |