ML20211K666

Requests Addl Info Re 760419 Application for License to Participate in Investigational Program Utilizing Coratomic Model C-101 nuclear-powered Pacemakers,Including List of Surgeon Members of Study Team

ML20211K666
Person / Time
Site:	07002213
Issue date:	05/17/1976
From:	Vacca P NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Cook G CLEVELAND CLINIC FOUNDATION, CLEVELAND, OH
Shared Package
ML20211K381	List: ML20211K376 ML20211K413 ML20211K459 ML20211K538 ML20211K582 ML20211K619 ML20211K666 ML20211K681 ML20211K706 ML20211K731 ML20211K761 ML20211K774
References
NUDOCS 8702260647
Download: ML20211K666 (2)

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.f i Cleveland Clinic M ATTN: Gilbert Cook Hospital Administrator w.

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Gentlemen ,

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This refers to your application dated April 19, 1976 (received May 3, 1976), for a special nuclear materials license to participate in the investigational program utilizing Coratomic Model C-101 nuclear powered l

pacemakers.

, During the investigational phase of nucloar pacemaker use, licenses are NPJ.' ' being issued only to medical institutions that can assure continuity of 3D followup of patients with implanted pacemakers, and not to individual MR physicians. The physicians designated in an application as responsible

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investigators should have substantial experience with pacemakers in the lg[ specialties of cardiology and thoracic surgery, and the applicant medical institution will generally be expected to have an established program for the implantation and followup of cadiac pacemakers. A study team 1

! . approach is emphasized. With reference to the above, your application j .[, should be supported with the additional information listed below:

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' in~L$@ a. List the surgeon member (s) of your study team and supply the following information for each surgeon:

$sks iii,W Names

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, State in which licensed to practices

%. N Specialty board certification: ,

Position with the applicant 3_ y , g Previous experience as given for other members of the i

N o. study team.

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M Iif' $ b. The other physicians responsibic for the participating in the study as members of your study team should each certify that

c. e he is familiar with the Coratonic Model C-101 protocol and i N0 J 0' understands that the issuing of the license to Cleveland clinic is conditioned upon the following of the protocol.

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h.Or g Foran AEC 318 (Rev. 9 53) AICM 0240 W u. e. oovannuant enintime orrects so74.eas s ee

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ApQ.fi. the requested information. Please reference Docket No. 70-2213 in your h.- reply.

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3401,p Patricia C. Vacca Qi'yt[ Radioisotopes Licensing Branch

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