PMA P180037S012

Device
Venovo™ Venous Stent System
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P180037
Supplement
S012
Product code
QAN
Decision date
2023-02-02
Generic name
Stent, iliac vein
Approval order statement
New supplier for a delivery system wheel sub-assembly.

Current openFDA PMA Record#

Device
Venovo™ Venous Stent System
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P180037
Supplement
S012
Product code
QAN
Generic name
Stent, iliac vein
Decision date
2023-02-02
Decision code
OK30
Date received
2023-01-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New supplier for a delivery system wheel sub-assembly.