Back to Results
First PageMeta Content
Health / Center for Devices and Radiological Health / Premarket approval / Medical device / Federal Food / Drug / and Cosmetic Act / Title 21 of the Code of Federal Regulations / Adverse event / Investigational Device Exemption / Unique Device Identification / Food and Drug Administration / Medicine / Technology


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue Document Control Room -WO66-G609
Add to Reading List

Document Date: 2013-12-06 12:10:53

Open Document

File Size: 248,53 KB

Share Result on Facebook

City

Rosa / Rockville / /

Company

Medtronic / Unocal / Assurant / /

Currency

pence / /

Event

FDA Phase / /

IndustryTerm

Internet HomePage / similar device / malfunctioned and such device / diagnostic devices / /

MedicalCondition

serious injury / /

Organization

Radiological Health PMA Document Mail Center / Food and Drug Administration / Cardiovascular Devices Office / U.S. Food and Drug Administration Center for Devices / DEPARTMENT OF HEALTH / Center for Devices / /

Person

Silver Spring / Gerardine Finn Continued / Brain D. Zuckerman / Gerardine Finn / /

/

Position

Vice President / Regulatory Affairs Coronary / Director Division / M.D. Director Division / /

Product

Cobalt Iliac Balloon-Expandable Stent System / PMA supplement / /

ProvinceOrState

Maryland / California / /

Technology

approved protocol / /

URL

www.fda.gov/Safet/Recalls/IndustryGuidance/default.htm / http /

SocialTag