LiDCO Ltd. / EDWARDS LIFESCIENCES LLC / K134035 Trade / Transonic Systems Inc. / /
Facility
New Hampshire Avenue Document Control Center / /
IndustryTerm
announcements concerning your device / predicate devices / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address http /
MedicalCondition
stroke / /
Organization
Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure K134035 Indications for Use / Cardiovascular Devices Office / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / CDRH's office of Surveillance / /
Person
Bram D. Zuckerman / Silver Spring / Ken Skodacek / / /
Position
VP / Engineering and Clinical Studies / Director Division / M.D. Director Division / /
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration