PMA P180037S005

Device
Venovo Venous Stent System
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P180037
Supplement
S005
Product code
QAN
Decision date
2021-06-03
Generic name
Stent, iliac vein
Approval order statement
New supplier and manufacturing processes for delivery system handle components.

Current openFDA PMA Record#

Device
Venovo Venous Stent System
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P180037
Supplement
S005
Product code
QAN
Generic name
Stent, iliac vein
Decision date
2021-06-03
Decision code
OK30
Date received
2021-05-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New supplier and manufacturing processes for delivery system handle components.