PMA P060002S005

Device
BARD FLAIR ENDOVASCULAR STENT GRAFT
Applicant
Bard Peripheral Vascular
PMA number
P060002
Supplement
S005
Product code
PFV
Decision date
2009-09-04
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 OF THE POST-APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record#

Device
BARD FLAIR ENDOVASCULAR STENT GRAFT
Applicant
Bard Peripheral Vascular
PMA number
P060002
Supplement
S005
Product code
PFV
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date
2009-09-04
Decision code
APPR
Date received
2009-07-22
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.