PMA P060002S033

Device
FLAIR ENDOVASCULAR STENT GRAFT
Applicant
Bard Peripheral Vascular
PMA number
P060002
Supplement
S033
Product code
PFV
Decision date
2013-09-16
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
ALTERNATE TIP CLEANING PROCESS.

Current openFDA PMA Record#

Device
FLAIR ENDOVASCULAR STENT GRAFT
Applicant
Bard Peripheral Vascular
PMA number
P060002
Supplement
S033
Product code
PFV
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date
2013-09-16
Decision code
OK30
Date received
2013-08-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE TIP CLEANING PROCESS.