PMA P060002S010

Device
BARD FLAIR ENDOVASCULAR STENT GRAFT
Applicant
Bard Peripheral Vascular
PMA number
P060002
Supplement
S010
Product code
PFV
Decision date
2010-09-15
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 A MODIFICATION TO THE PROCEDURES FOR IMPLEMENTING SHELF LIVES OF RAW MATERIALS.

Current openFDA PMA Record#

Device
BARD FLAIR ENDOVASCULAR STENT GRAFT
Applicant
Bard Peripheral Vascular
PMA number
P060002
Supplement
S010
Product code
PFV
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date
2010-09-15
Decision code
APPR
Date received
2010-03-19
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MODIFICATION TO THE PROCEDURES FOR IMPLEMENTING SHELF LIVES OF RAW MATERIALS.