PMA P180037S015

Device
Venovo™ Venous Stent System
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P180037
Supplement
S015
Product code
QAN
Decision date
2026-06-10
Classification
Cardiovascular
Generic name
Stent, iliac vein
Approval order statement
changes to the packaging supplier's adhesive coating

Current openFDA PMA Record#

Device
Venovo™ Venous Stent System
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P180037
Supplement
S015
Product code
QAN
Generic name
Stent, iliac vein
Decision date
2026-06-10
Decision code
OK30
Date received
2026-05-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
changes to the packaging supplier's adhesive coating