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ATTN: Gilbert Cook Hospital Administrator 9500 Eucled Avenue
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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
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.
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
During the investigational phase of nucloar pacemaker use, licenses are NPJ.' '
' 7'+.        .
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
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
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!                .                                          approach is emphasized. With reference to the above, your application j .[,                                                       should be supported with the additional information listed below:
investigators should have substantial experience with pacemakers in the lg[
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specialties of cardiology and thoracic surgery, and the applicant medical institution will generally be expected to have an established 1
' in~L$@                                                            a. List the surgeon member (s) of your study team and supply the following information for each surgeon:
program for the implantation and followup of cadiac pacemakers. A study team approach is emphasized. With reference to the above, your application j.[,
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J.a                                                                       Telephone number:
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    ~*M
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    %. N Specialty board certification:                                                                                             ,
~*M State in which licensed to practices Specialty board certification:
Position with the applicant 3_       y                  ,        g                                         Previous experience as given for other members of the i
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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
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: 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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study as members of your study team should each certify that c.
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: g g...j We will continue our review of your application promptly upon receipt of
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the requested information. Please reference Docket No. 70-2213 in your ApQ.fi.
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Sincerely, m.
Sincerely, m.
g                                                                                           .-
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'w 3401,p Patricia C. Vacca Qi'yt[
3401,p                                                                                                     Patricia C. Vacca Qi'yt[                                                                                                       Radioisotopes Licensing Branch
Radioisotopes Licensing Branch
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Latest revision as of 22:02, 5 December 2024

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:
References
NUDOCS 8702260647
Download: ML20211K666 (2)
v • d • e


Text

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i Cleveland Clinic M

ATTN: Gilbert Cook Hospital Administrator 9500 Eucled Avenue

,.G, w.

Cleveland, Ohio 44106 p.-

2yf Gentlemen

,in.,...

o **

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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

' 7'+.

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 1

program for the implantation and followup of cadiac pacemakers. A study team approach is emphasized. With reference to the above, your application j.[,

should be supported with the additional information listed below:

l gaggang a.

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

$sks iii,W Names Office address:

J.a Telephone number:

~*M State in which licensed to practices Specialty board certification:

N Position with the applicant 3_

g Previous experience as given for other members of the y

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study team.

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b.

The other physicians responsibic for the participating in the M

study as members of your study team should each certify that c.

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...M... a,0 J 0' clinic is conditioned upon the following of the protocol.

N m

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reply.

Sincerely, m.

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'w 3401,p Patricia C. Vacca Qi'yt[

Radioisotopes Licensing Branch

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