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Interventional radiology / Cardiology / Sensei robotic catheter system / Percutaneous coronary intervention / Hansen Medical / Percutaneous / Catheter / Stent / Computer assisted surgery / Medicine / Implants / Surgery


Document Date: 2012-08-06 18:53:18

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City

Baltimore / /

Company

MNS wlNavigant Navigation Workstation (NWSO5) Stereotaxis Inc. / Regulatory Affairs Consulting Agent CardioMed Device Consultants LLC / Stereotaxis / System Sensei Robotic Catheter System Corindus Inc. / CorPath 200 System / Hansen Medical Inc. / K120834 Trade / Corindus Inc. / Navigant / CardioMed Device Consultants LLC / /

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IndustryTerm

overall device / announcements concerning your device / predicate devices / touch screen technology / stent/balloon devices / Internet address http /

MedicalCondition

Irritation / /

MedicalTreatment

catheter / catheters / radiation / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / Description PCI Device Advancement Force Test PCI Device Advancement Force / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / Bedside Unit / Cardiovascular Devices Office / Division of Small Manufacturers / International and Consumer Assistance / Core Laboratory / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / Division of Cardiovascular Devices / /

Person

Mona Advani / Silver Spring / Adverse Cardiac / Mona Advami / Michail M. Pankratov / /

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Position

Vice President / Clinical / physician / Operational Principles The physician / Major / /

Product

K09 1808 DXX 21 CFR 870 / /

ProvinceOrState

Maryland / Massachusetts / /

Technology

radiation / radiation shield / touch screen technology / ADO / /

URL

http /

SocialTag