PMA P170042S011

Device: Covera™ Vascular Covered Stent
Applicant: C.R. Bard, Inc.
PMA number: P170042
Supplement: S011
Product code: PFV
Decision date: 2022-03-24
Generic name: System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Approval order statement: Approval for an update to the labeling to include the 36-month data on patients enrolled in the AVeNEW IDE extended follow-up study.

Current openFDA PMA Record#

Device: Covera™ Vascular Covered Stent
Applicant: C.R. Bard, Inc.
PMA number: P170042
Supplement: S011
Product code: PFV
Generic name: System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date: 2022-03-24
Decision code: APPR
Date received: 2021-08-20
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for an update to the labeling to include the 36-month data on patients enrolled in the AVeNEW IDE extended follow-up study.