PMA P170042S006

Device
Covera Vascular Covered Stent
Applicant
C.R. Bard, Inc.
PMA number
P170042
Supplement
S006
Product code
PFV
Decision date
2020-08-20
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Approval order statement
Modifications to the delivery system joint bonding process.

Current openFDA PMA Record#

Device
Covera Vascular Covered Stent
Applicant
C.R. Bard, Inc.
PMA number
P170042
Supplement
S006
Product code
PFV
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date
2020-08-20
Decision code
OK30
Date received
2020-08-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modifications to the delivery system joint bonding process.