PMA P100013S022

Device
Exoseal® Vascular Closure Device
Applicant
Cordis US Corporation
PMA number
P100013
Supplement
S022
Product code
MGB
Decision date
2021-11-02
Generic name
Device, hemostasis, vascular
Approval order statement
Use of a second supplier for the plunger disk component of the 7F Exoseal Vascular Closure Device.

Current openFDA PMA Record#

Device
Exoseal® Vascular Closure Device
Applicant
Cordis US Corporation
PMA number
P100013
Supplement
S022
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2021-11-02
Decision code
OK30
Date received
2021-10-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use of a second supplier for the plunger disk component of the 7F Exoseal Vascular Closure Device.