BARD FLAIR ENDOVASCULAR STENT GRAFT
FDA premarket approval P060002/S011 · decided 2010-04-16
Approval details
- PMA number
- P060002
- Supplement
- S011
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BARD FLAIR ENDOVASCULAR STENT GRAFT
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Applicant
- Bard Peripheral Vascular
- Date received
- 2010-03-19
- Decision date
- 2010-04-16
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR MODIFICATIONS TO THE DEVICE INSTRUCTIONS FOR USE TO INCLUDE LANGUAGE TO IMPROVE THE SAFETY IN USE OF THE DEVICE, PREDOMINANTLY WITH RESPECT TO THE POTENTIAL FOR DEVICE MIGRATIONS.
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| 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 |