PMA P170042S015

Device
Covera™ Vascular Covered Stent
Applicant
C.R. Bard, Inc.
PMA number
P170042
Supplement
S015
Product code
PFV
Decision date
2026-06-10
Classification
Cardiovascular
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Approval order statement
changes to the packaging supplier's adhesive coating

Current openFDA PMA Record#

Device
Covera™ Vascular Covered Stent
Applicant
C.R. Bard, Inc.
PMA number
P170042
Supplement
S015
Product code
PFV
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date
2026-06-10
Decision code
OK30
Date received
2026-05-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
changes to the packaging supplier's adhesive coating