PMA P130029S015

Device: Fluency™ Plus Endovascular Stent Graft
Applicant: Bard Peripheral Vascular, Inc.
PMA number: P130029
Supplement: S015
Product code: PFV
Decision date: 2026-06-22
Classification: Cardiovascular
Generic name: System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Approval order statement: changes to manufacturing equipment for packaging of the Bard Fluency Plus Endovascular Stent Graft

Current openFDA PMA Record#

Device: Fluency™ Plus Endovascular Stent Graft
Applicant: Bard Peripheral Vascular, Inc.
PMA number: P130029
Supplement: S015
Product code: PFV
Generic name: System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date: 2026-06-22
Decision code: OK30
Date received: 2026-05-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes to manufacturing equipment for packaging of the Bard Fluency Plus Endovascular Stent Graft