PMA P180037S003

Device
Venovo Venous Stent System
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P180037
Supplement
S003
Product code
QAN
Decision date
2020-09-25
Generic name
Stent, iliac vein
Approval order statement
Alternate supplier of delivery system handle lock marking and thermoplastic staking processes.

Current openFDA PMA Record#

Device
Venovo Venous Stent System
Applicant
Bard Peripheral Vascular, Inc.
PMA number
P180037
Supplement
S003
Product code
QAN
Generic name
Stent, iliac vein
Decision date
2020-09-25
Decision code
OK30
Date received
2020-08-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternate supplier of delivery system handle lock marking and thermoplastic staking processes.