PMA P170042S001

Device
Covera™ Vascular Covered Stent
Applicant
C.R. Bard, Inc.
PMA number
P170042
Supplement
S001
Product code
PFV
Decision date
2018-08-27
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 for the addition of a dimensional inspection for a delivery system component.

Current openFDA PMA Record#

Device
Covera™ Vascular Covered Stent
Applicant
C.R. Bard, Inc.
PMA number
P170042
Supplement
S001
Product code
PFV
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date
2018-08-27
Decision code
APPR
Date received
2018-08-20
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for the addition of a dimensional inspection for a delivery system component.