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Pharmaceutical sciences / Pharmaceutical industry / Pharmacology / Food and Drug Administration / Clinical trial / Form FDA 483 / Clinical investigator / Investigational Device Exemption / Institutional review board / Research / Clinical research / Health


FDA Warning Letter to Solta Medical, Inc[removed]
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Document Date: 2013-02-19 10:32:47


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File Size: 107,24 KB

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City

Silver Spring / Alameda / Hayward / /

Company

UNITED PARCEL SERVICE / Steven D. Silverman / Solta Medical Inc. / /

/

Facility

Harbor Bay Pkwy / New Hampshire Avenue Building / /

IndustryTerm

particular site / email communications / clinical monitoring services / investigational device / device operator / laser protocols / /

MedicalCondition

disease / eye injury / infection / /

OperatingSystem

ISIS / /

Organization

Compliance Center for Devices and Radiological Health / FDA’s San Francisco District Office / Institutional Review Board / Food and Drug Administration / Division of Bioresearch Monitoring / Food and Drug Administration Center for Devices / /S/ Steven D. Silverman Director Office / FDA San Francisco District Office / Department of Health and Human Services / Radiological Health office of Compliance Division of Bioresearch Monitoring / /

Person

Veronica Calvin / /

/

Position

investigator / Governor / Director of Clinical Programs / Stephen J. Fanning President & Chief Executive Officer / clinical investigator / participating investigator / /

ProvinceOrState

Maryland / California / /

Technology

Laser / lasers / Janus laser protocols / /

URL

http /

SocialTag