PMA P150022S003

Device
Closer Vascular Sealing System (VSS)
Applicant
Rex Medical, L.P.
PMA number
P150022
Supplement
S003
Product code
MGB
Decision date
2018-01-31
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
Approval for design changes to the delivery system as well as packaging changes to the delivery system and access kit.

Current openFDA PMA Record#

Device
Closer Vascular Sealing System (VSS)
Applicant
Rex Medical, L.P.
PMA number
P150022
Supplement
S003
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2018-01-31
Decision code
APPR
Date received
2017-11-02
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for design changes to the delivery system as well as packaging changes to the delivery system and access kit.