Closer Vascular Sealing System (VSS)

Device, Hemostasis, Vascular

FDA Premarket Approval P150022 S005

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 a change to the maximum tightening force exerted by the delivery system during device deployment.

DeviceCloser Vascular Sealing System (VSS)
Classification NameDevice, Hemostasis, Vascular
Generic NameDevice, Hemostasis, Vascular
ApplicantREX MEDICAL, L.P.
Date Received2018-05-21
Decision Date2018-07-10
PMAP150022
SupplementS005
Product CodeMGB
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address REX MEDICAL, L.P. 555 E. North Lane Suite 5035 conshohocken, PA 19428

Supplemental Filings

Supplement NumberDateSupplement Type
P150022Original Filing
S007 2018-09-11 30-day Notice
S006
S005 2018-05-21 Real-time Process
S004 2018-01-08 Special (immediate Track)
S003 2017-11-02 Real-time Process
S002 2016-08-15 Real-time Process
S001 2016-03-15 Real-time Process

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