FLAIR ENDOVASCULAR STENT GRAFT
FDA premarket approval P060002/S034 · decided 2014-08-13
Approval details
- PMA number
- P060002
- Supplement
- S034
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- FLAIR ENDOVASCULAR STENT GRAFT
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Applicant
- Bard Peripheral Vascular
- Date received
- 2014-02-14
- Decision date
- 2014-08-13
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR UPDATED INSTRUCTIONS FOR USE (IFU) TO INCLUDE DATA FROM THE POSTAPPROVAL STUDY (RENOVA).
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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 |
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| FLUENCY TRACHEOBRONCHIAL STENT GRAFT (K031041) | Bard Peripheral Vascular | 2003-06-19 |