PMA P060002

Device
Flair Endovascular Stent Graft
Applicant
Bard Peripheral Vascular
PMA number
P060002
Supplement
S040
Product code
PFV
Decision date
2018-10-11
Classification
System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Approval order statement
Approval for adding a sterilization line at the Bard Regional Sterilization, Madison Facility.
Summary
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Current openFDA PMA Record#

Device
Flair Endovascular Stent Graft
Applicant
Bard Peripheral Vascular
PMA number
P060002
Supplement
S040
Product code
PFV
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date
2018-10-11
Decision code
APPR
Date received
2018-03-16
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for adding a sterilization line at the Bard Regional Sterilization, Madison Facility.