PMA P100013S014

Device: EXOSEAL Vascular Closure Device
Applicant: Cordis US Corporation
PMA number: P100013
Supplement: S014
Product code: MGB
Decision date: 2017-08-07
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: Approval for the addition of Cordis Corporation, Miami Lakes, Florida as an alternate supplier for the Delivery Shaft component of the 6F EXOSEAL Vascular Closure Device.

Current openFDA PMA Record#

Device: EXOSEAL Vascular Closure Device
Applicant: Cordis US Corporation
PMA number: P100013
Supplement: S014
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2017-08-07
Decision code: APPR
Date received: 2017-04-11
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the addition of Cordis Corporation, Miami Lakes, Florida as an alternate supplier for the Delivery Shaft component of the 6F EXOSEAL Vascular Closure Device.