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Food and Drug Administration / Organ failure / Renal dialysis / Hemodialysis / Hemofiltration / Dialysis / Gambro / Ultrafiltration / Medical device / Medicine / Membrane technology / Nephrology


Document Date: 2013-04-11 12:52:58

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City

Lawrence / /

Company

K123395 NxStage Medical Inc. / mL (Set total) K123395 NxStage Medical Inc. / Volume Set Gambro Prisma M60 Set Minntech HF / K123395 Trade / NxStage Medical Inc. / Premarket Notification NxStage Medical Inc. / 7 K123395 NxStage Medical Inc. / Steris / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

therapies for patients who have acute renal failure / announcements concerning your device / predicate devices / manufacturing practice requirements / marketed predicate devices / treatment of acute and chronic renal failure / manufacturing practice / fluid management device / /

MarketIndex

set 40 / /

MedicalCondition

chronic care dialysis facility / acute and chronic renal failure / acute renal failure / chronic care facility / /

MedicalTreatment

venovenous hemofiltration / hemodialysis / renal replacement therapies / hemodiafiltration / dialysis / hemofiltration / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / Division of Reproductive / FDA / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / Reproductive / Gastro-Renal / and Urological Devices Office / /

Person

Mary Lou Stroumbos / Silver Spring / Benjamin R. Fisher / /

/

Position

prescribing physician / Manager 350 Merrimack Street LAWRENCE MA / Director / physician / Cycler / Regulatory Affairs Manager / /

Product

NxStage System / Federal Food / K061837 / /

ProvinceOrState

Massachusetts / /

Technology

radiation / dialysis / /

URL

http /

SocialTag