PMA P140018S018

Device
VenaSeal Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S018
Product code
PJQ
Decision date
2020-01-25
Generic name
Agent, occluding, vascular, permanent
Approval order statement
Approval for an update to the instructions for use adding the option to deliver up to 3 aliquots of the device prior to compression.

Current openFDA PMA Record#

Device
VenaSeal Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S018
Product code
PJQ
Generic name
Agent, occluding, vascular, permanent
Decision date
2020-01-25
Decision code
APPR
Date received
2019-10-28
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for an update to the instructions for use adding the option to deliver up to 3 aliquots of the device prior to compression.