VenaSeal Closure System

FDA Premarket Approval P140018 S032

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

DeviceVenaSeal Closure System
Generic NameAgent, Occluding, Vascular, Permanent
ApplicantMEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP140018 Supplement NumberS032 Date Received04/29/2022 Decision Date07/27/2022 Product Code PJQ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-04-29
Decision Date2022-07-27
PMAP140018
SupplementS032
Product CodePJQ 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressMEDTRONIC VASCULAR INC
3033 Campus Drive
plymouth, MN 55441 PMA NumberP140018 Supplement NumberS032 Date Received04/29/2022 Decision Date07/27/2022 Product Code PJQ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For Design Changes To The Dispenser Gun Component Of The VenaSeal Closure System.

Supplemental Filings

Supplement NumberDateSupplement Type
P140018Original Filing
S032 2022-04-29 Real-time Process
S031 2022-01-21 30-day Notice
S030 2021-11-30 30-day Notice
S029
S028 2021-09-23 30-day Notice
S027
S026
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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