PMA P100013S023

Device: Cordis® EXOSEAL® Vascular Closure Device
Applicant: Cordis US Corporation
PMA number: P100013
Supplement: S023
Product code: MGB
Decision date: 2021-12-15
Generic name: Device, hemostasis, vascular
Approval order statement: Change in the method used in the determination of the E-beam dosage and the loading configuration used during sterilization of the EXOSEAL® Vascular Closure Device (VCD).

Current openFDA PMA Record#

Device: Cordis® EXOSEAL® Vascular Closure Device
Applicant: Cordis US Corporation
PMA number: P100013
Supplement: S023
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2021-12-15
Decision code: OK30
Date received: 2021-11-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in the method used in the determination of the E-beam dosage and the loading configuration used during sterilization of the EXOSEAL® Vascular Closure Device (VCD).