PMA P150022

Device
Closer Vascular Sealing System (VSS)
Applicant
Rex Medical, L.P.
PMA number
P150022
Supplement
S007
Product code
MGB
Decision date
2018-10-01
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
Addition of an alternate vendor for the tipping process.

Current openFDA PMA Record#

Device
Closer Vascular Sealing System (VSS)
Applicant
Rex Medical, L.P.
PMA number
P150022
Supplement
S007
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2018-10-01
Decision code
OK30
Date received
2018-09-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of an alternate vendor for the tipping process.