PMA P140018S038

Device
VenaSeal Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S038
Product code
PJQ
Decision date
2023-09-06
Classification
Cardiovascular
Generic name
Agent, occluding, vascular, permanent
Approval order statement
Implement the VenaSeal Vision System for inspecting VenaSeal kit components.

Current openFDA PMA Record#

Device
VenaSeal Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S038
Product code
PJQ
Generic name
Agent, occluding, vascular, permanent
Decision date
2023-09-06
Decision code
OK30
Date received
2023-08-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implement the VenaSeal Vision System for inspecting VenaSeal kit components.