PMA P060002S035

Device
BARD FLAIR ENDOVASCULAR STENT GRAFT
Applicant
Bard Peripheral Vascular
PMA number
P060002
Supplement
S035
Product code
PFV
Decision date
2014-04-23
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
NEW MEASURING EQUIPMENT FOR USE IN INCOMING QUALITY CONTROL (IQC) INSPECTIONS.

Current openFDA PMA Record#

Device
BARD FLAIR ENDOVASCULAR STENT GRAFT
Applicant
Bard Peripheral Vascular
PMA number
P060002
Supplement
S035
Product code
PFV
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date
2014-04-23
Decision code
OK30
Date received
2014-03-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
NEW MEASURING EQUIPMENT FOR USE IN INCOMING QUALITY CONTROL (IQC) INSPECTIONS.