PMA P060002S007

Device
FLAIR ENDOVASCULAR STENT GRAFT
Applicant
Bard Peripheral Vascular
PMA number
P060002
Supplement
S007
Product code
PFV
Decision date
2009-12-02
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
CHANGE IN ENVIRONMENTAL MONITORING TESTING.

Current openFDA PMA Record#

Device
FLAIR ENDOVASCULAR STENT GRAFT
Applicant
Bard Peripheral Vascular
PMA number
P060002
Supplement
S007
Product code
PFV
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date
2009-12-02
Decision code
OK30
Date received
2009-11-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN ENVIRONMENTAL MONITORING TESTING.