Back to Results
First PageMeta Content
Technology / Clinical research / Food law / Pharmaceutical industry / Pharmacology / Center for Devices and Radiological Health / Premarket approval / Medical device / Federal Food / Drug / and Cosmetic Act / Medicine / Food and Drug Administration / Health


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue
Add to Reading List

Document Date: 2014-11-21 11:22:41

Open Document

File Size: 41,81 KB

Share Result on Facebook

City

St. Paul / Rockville / /

Country

United States / /

Currency

pence / /

Event

Product Issues / Product Recall / /

Facility

New Hampshire Avenue Document Control Center / /

IndustryTerm

Internet HomePage / similar device / diagnostic devices / /

MedicalCondition

symptomatic paroxysmal atrial fibrillation / serious injury / tachycardia / refractory recurrent symptomatic paroxysmal atrial fibrillation / chronic performance / atrial flutter / /

MedicalTreatment

Catheter / /

Organization

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

Person

Bram D. Zuckerman / Silver Spring / Jennifer Zwiefelhofer / Zwiefelhofer Continued / Deborah Castillo / /

/

Position

Director / Regulatory Affairs St. Jude / Director Division / M.D. Director Division / /

Product

approval of the PMA / /

ProvinceOrState

Minnesota / Maryland / /

Technology

alpha / PAS protocol / approved PAS protocol / approved protocol / /

URL

www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm / www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089274.h / www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/P / www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm / /

SocialTag