Covera Vascular Covered Stent
FDA premarket approval P170042 · decided 2018-07-30
Approval details
- PMA number
- P170042
- Trade name
- Covera Vascular Covered Stent
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Applicant
- C.R. Bard, Inc.
- Date received
- 2017-12-12
- Decision date
- 2018-07-30
- Days to decision
- 230 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval of the Covera Vascular Covered Stent. This device is indicated for use in the treatment of stenoses at the venous anastomosis of ePTFE and other synthetic arterio-venous (AV) access grafts.
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