VenaSeal Closure System

FDA Premarket Approval P140018 S028

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

Use of an alternative biological indicator (bi) for use in sterilization of the venaseal closure system

DeviceVenaSeal Closure System
Generic NameAgent, Occluding, Vascular, Permanent
Date Received2021-09-23
Decision Date2021-10-06
Product CodePJQ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
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
S028 2021-09-23 30-day Notice
S025 2021-04-23 Special (immediate Track)
S023 2021-02-25 30-day Notice
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


Device IDPMASupp
20643169986262 P140018 006
00763000240776 P140018 018

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