PMA P150022S005

Device
Closer Vascular Sealing System (VSS)
Applicant
Rex Medical, L.P.
PMA number
P150022
Supplement
S005
Product code
MGB
Decision date
2018-07-10
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
Approval for a change to the maximum tightening force exerted by the delivery system during device deployment.

Current openFDA PMA Record#

Device
Closer Vascular Sealing System (VSS)
Applicant
Rex Medical, L.P.
PMA number
P150022
Supplement
S005
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2018-07-10
Decision code
APPR
Date received
2018-05-21
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a change to the maximum tightening force exerted by the delivery system during device deployment.