Venaseal Closure System

FDA Premarket Approval P140018 S025

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Additional verification of the date of manufacture and use by date for devices undergoing rework activities

DeviceVenaseal Closure System
Generic NameAgent, Occluding, Vascular, Permanent
ApplicantMEDTRONIC VASCULAR INC
Date Received2021-04-23
Decision Date2021-05-21
PMAP140018
SupplementS025
Product CodePJQ 
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC VASCULAR INC 3033 Campus Drive plymouth, MN 55441

Supplemental Filings

Supplement NumberDateSupplement Type
P140018Original Filing
S025 2021-04-23 Special (immediate Track)
S024
S023 2021-02-25 30-day Notice
S022
S021 2020-10-19 Real-time Process
S020 2020-08-24 30-day Notice
S019 2020-03-10 Special (immediate Track)
S018 2019-10-28 Normal 180 Day Track
S017 2019-09-25 Real-time Process
S016 2019-08-09 30-day Notice
S015 2019-05-24 30-day Notice
S014 2018-11-16 30-day Notice
S013 2018-09-24 30-day Notice
S012 2018-08-10 30-day Notice
S011 2018-03-27 30-day Notice
S010 2018-03-05 30-day Notice
S009 2018-02-26 30-day Notice
S008 2017-08-04 Normal 180 Day Track
S007 2017-06-13 Special (immediate Track)
S006 2017-05-18 Normal 180 Day Track No User Fee
S005 2016-11-01 30-day Notice
S004 2016-09-07 Normal 180 Day Track No User Fee
S003 2016-07-26 30-day Notice
S002 2016-06-27 30-day Notice
S001 2015-07-28 Real-time Process

NIH GUDID Devices

Device IDPMASupp
20643169986262 P140018 006
00763000240776 P140018 018

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