Covera Vascular Covered Stent
FDA premarket approval P170042/S002 · decided 2019-03-01
Approval details
- PMA number
- P170042
- Supplement
- S002
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2018-09-04
- Decision date
- 2019-03-01
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval of the COVERA Vascular Covered Stent. The device is indicated for use in hemodialysis patients for the treatment of stenoses in the venous outflow of an arterio-venous fistula and at the venous anastomosis of an ePTFE or other synthetic AV graft.
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