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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 / Quality management system / Investigational Device Exemption / Food and Drug Administration / Medicine / Technology


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue
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Document Date: 2014-03-05 09:38:55

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File Size: 41,98 KB

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City

Security Boulevard Baltimore / Bedford / Rockville / /

Company

Anika Therapeutics Incorporated / /

Currency

pence / /

Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

IndustryTerm

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

MedicalCondition

osteoarthritis / pain / serious injury / /

Organization

Orthopedic Devices Office / Radiological Health PMA Document Mail Center / Food and Drug Administration / Center for Devices and Radiological Health / Radiological Health / CMS office of Coverage Policy / U.S. Food and Drug Administration Center for Devices / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Mark N. Melkerson Director Division / Center for Devices / /

Person

Silver Spring / Carol Pekar / Coverage / Mark N. Melkerson / Hany W. Demian / /

/

Position

Director / Vice President / /

Product

acetaminophen / MONOVISC™ Injectable Intra / PMA supplement / /

ProvinceOrState

Maryland / Massachusetts / /

Technology

approved protocol / /

URL

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

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