PMA P060002S015

Device
BARD FLAIR ENDOVASCULAR STENT GRAFT
Applicant
Bard Peripheral Vascular
PMA number
P060002
Supplement
S015
Product code
PFV
Decision date
2010-09-08
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
UPGRADE TO THE MAINTENANCE MANAGEMENT SOFTWARE PROGRAM USED TO TRACK AND SCHEDULE PREVENTATIVE MAINTENANCE TALK, EQUIPMENT, AND SUPPLIES.

Current openFDA PMA Record#

Device
BARD FLAIR ENDOVASCULAR STENT GRAFT
Applicant
Bard Peripheral Vascular
PMA number
P060002
Supplement
S015
Product code
PFV
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date
2010-09-08
Decision code
OK30
Date received
2010-08-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
UPGRADE TO THE MAINTENANCE MANAGEMENT SOFTWARE PROGRAM USED TO TRACK AND SCHEDULE PREVENTATIVE MAINTENANCE TALK, EQUIPMENT, AND SUPPLIES.