VASCADE MVP Venous Vascular Closure System (VVCS)

Device, Hemostasis, Vascular

FDA Premarket Approval P120016 S024

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

Approval for percutaneous closure of femoral venous access sites while reducing time to ambulation, total post-procedure time, time to hemostasis, and time to discharge eligibility in patients who have undergone catheter-based procedures utilizing 6-12f inner diameter procedural sheaths, with single or multiple access sites in one or both limbs.

DeviceVASCADE MVP Venous Vascular Closure System (VVCS)
Classification NameDevice, Hemostasis, Vascular
Generic NameDevice, Hemostasis, Vascular
ApplicantCARDIVA MEDICAL, INC.
Date Received2018-05-30
Decision Date2018-11-27
Notice Date2018-12-06
PMAP120016
SupplementS024
Product CodeMGB
Docket Number18M-4582
Advisory CommitteeCardiovascular
Supplement TypePanel Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address CARDIVA MEDICAL, INC. 2900 Lakeside Drive suite 160 santa Clara, CA 95054
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P120016Original Filing
S030 2022-10-11 30-day Notice
S029
S028 2021-02-08 Normal 180 Day Track
S027 2019-07-08 Normal 180 Day Track
S026 2018-11-23 Normal 180 Day Track No User Fee
S025 2018-07-10 Real-time Process
S024 2018-05-30 Panel Track
S023 2017-03-20 30-day Notice
S022 2017-01-17 30-day Notice
S021 2016-11-04 Normal 180 Day Track
S020 2016-06-03 Real-time Process
S019 2016-01-07 30-day Notice
S018 2015-11-16 30-day Notice
S017 2015-11-03 135 Review Track For 30-day Notice
S016 2015-06-29 Special (immediate Track)
S015 2015-05-18 Real-time Process
S014 2015-04-03 Normal 180 Day Track No User Fee
S013 2015-03-12 30-day Notice
S012 2015-03-03 30-day Notice
S011 2015-02-25 30-day Notice
S010 2015-02-18 30-day Notice
S009 2015-02-09 30-day Notice
S008 2014-12-12 30-day Notice
S007 2014-10-20 30-day Notice
S006 2014-09-29 30-day Notice
S005 2014-08-18 135 Review Track For 30-day Notice
S004 2014-08-18 Real-time Process
S003 2014-06-27 30-day Notice
S002 2014-03-31 Real-time Process
S001 2014-03-18 30-day Notice

NIH GUDID Devices

Device IDPMASupp
M729700580I1 P120016 000
M729700500DX1 P120016 000
M729800612C2 P120016 024
M7298001012XL2 P120016 029

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