PMA P130029S013

Device: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
Applicant: Bard Peripheral Vascular, Inc.
PMA number: P130029
Supplement: S013
Product code: PFV
Decision date: 2025-08-13
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 Fluency Plus Endovascular Stent Graft

Current openFDA PMA Record#

Device: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
Applicant: Bard Peripheral Vascular, Inc.
PMA number: P130029
Supplement: S013
Product code: PFV
Generic name: System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date: 2025-08-13
Decision code: OK30
Date received: 2025-07-18
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 Fluency Plus Endovascular Stent Graft