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Food and Drug Administration / Pharmacology / Medical technology / Benign prostatic hyperplasia / Investigational Device Exemption / Prostate / Transurethral microwave thermotherapy / Medical device / Lower urinary tract symptoms / Medicine / Clinical research / Pharmaceutical industry


  Guidance for Industry and   Food and Drug Administration   Staff  Guidance for the Non‐Clinical and 
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City

Rockville / /

Company

H. Software / EMC / /

Continent

Asia / /

Country

France / Australia / Singapore / /

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Event

FDA Phase / /

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IndustryTerm

risk devices / treatment device / Treatment of Benign Prostatic Hyperplasia / similar devices / treatment of BPH / manufacturing / particular device / investigational device / premarket approval applications / /

MedicalCondition

BPH / disease / human benign prostatic hyperplasia / diseases / Benign Prostatic Hyperplasia / prostate cancer / /

MedicalTreatment

incision / prostatectomy / catheters / laser ablation / plastic surgery / surgical treatments / Thermotherapy / /

Organization

U.S. Department of Health and Human Services / Food and Drug Administration / Division of Dockets Management / Radiological Health office of Device Evaluation Division of Reproductive / Abdominal / and Radiological Devices Urology / Food and Drug Administration Center for Devices / American Urological Association / /

Person

James Seiler / John Baxley / /

Position

Investigator / Governor / Hunter / /

Product

Federal Food / /

ProvinceOrState

Maryland / /

PublishedMedium

Magnetic Resonance Imaging / /

Technology

Laser / lasers / Magnetic Resonance Imaging / Microwave / pdf / MRI / /

URL

http /

SocialTag