PMA P100013S024

Device
Cordis® Exoseal® Vascular Closure Device
Applicant
Cordis US Corporation
PMA number
P100013
Supplement
S024
Product code
MGB
Decision date
2022-03-01
Generic name
Device, hemostasis, vascular
Approval order statement
Relocation of the supplier of the Plunger Shaft and Indicator Wire Lumen Tube components.

Current openFDA PMA Record#

Device
Cordis® Exoseal® Vascular Closure Device
Applicant
Cordis US Corporation
PMA number
P100013
Supplement
S024
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2022-03-01
Decision code
OK30
Date received
2022-01-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Relocation of the supplier of the Plunger Shaft and Indicator Wire Lumen Tube components.