PMA P140018S036

Device
VenaSeal Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S036
Product code
PJQ
Decision date
2022-12-01
Generic name
Agent, occluding, vascular, permanent
Approval order statement
Implement an alternative bacterial water testing method.

Current openFDA PMA Record#

Device
VenaSeal Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S036
Product code
PJQ
Generic name
Agent, occluding, vascular, permanent
Decision date
2022-12-01
Decision code
OK30
Date received
2022-11-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implement an alternative bacterial water testing method.