PMA P180037S004

Device
Venovo Venous Stent System
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P180037
Supplement
S004
Product code
QAN
Decision date
2020-10-01
Generic name
Stent, iliac vein
Approval order statement
New equipment for the stent sheath stretching process.

Current openFDA PMA Record#

Device
Venovo Venous Stent System
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P180037
Supplement
S004
Product code
QAN
Generic name
Stent, iliac vein
Decision date
2020-10-01
Decision code
OK30
Date received
2020-09-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New equipment for the stent sheath stretching process.