PMA P170042S012

Device
Covera™ Vascular Covered Stent
Applicant
C.R. Bard, Inc.
PMA number
P170042
Supplement
S012
Product code
PFV
Decision date
2023-02-02
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Approval order statement
New supplier for a delivery system wheel sub-assembly.

Current openFDA PMA Record#

Device
Covera™ Vascular Covered Stent
Applicant
C.R. Bard, Inc.
PMA number
P170042
Supplement
S012
Product code
PFV
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date
2023-02-02
Decision code
OK30
Date received
2023-01-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New supplier for a delivery system wheel sub-assembly.