PMA P170042S013

Device: Covera™ Vascular Covered Stents
Applicant: C.R. Bard, Inc.
PMA number: P170042
Supplement: S013
Product code: PFV
Decision date: 2025-06-26
Classification: Cardiovascular
Generic name: System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Approval order statement: qualification of an additional manufacturing facility for the stent covering process for the Covera Vascular Covered Stent

Current openFDA PMA Record#

Device: Covera™ Vascular Covered Stents
Applicant: C.R. Bard, Inc.
PMA number: P170042
Supplement: S013
Product code: PFV
Generic name: System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date: 2025-06-26
Decision code: OK30
Date received: 2025-05-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: qualification of an additional manufacturing facility for the stent covering process for the Covera Vascular Covered Stent