PMA P170042S002
- Device
- Covera™ Vascular Covered Stent
- Applicant
- C.R. Bard, Inc.
- PMA number
- P170042
- Supplement
- S002
- Product code
- PFV
- Decision date
- 2019-03-01
- Classification
- System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Approval order 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf17/P170042S002B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- Covera™ Vascular Covered Stent
- Applicant
- C.R. Bard, Inc.
- PMA number
- P170042
- Supplement
- S002
- Product code
- PFV
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Decision date
- 2019-03-01
- Decision code
- APPR
- Date received
- 2018-09-04
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.