ML20211K731

Requests Addl Info Re Application for License to Participate in Clinical Evaluation of Nuclear Omni-Stanicor Model 184-A nuclear-powered Pacemaker,Including List of Cardiologist & Surgeon Members of Study Team

ML20211K731
Person / Time
Site:	07002213
Issue date:	03/30/1976
From:	Vacca P NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Castle L CLEVELAND CLINIC FOUNDATION, CLEVELAND, OH
Shared Package
ML20211K381	List: ML20211K376 ML20211K413 ML20211K459 ML20211K538 ML20211K582 ML20211K619 ML20211K666 ML20211K681 ML20211K706 ML20211K731 ML20211K761 ML20211K774
References
NUDOCS 8702260658
Download: ML20211K731 (2)

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Cleveland Clinic i

ATTH: Lon W. Castle, M.D.

The Clinic Center a4 Wit -

W,.9500 Euclid Avenue i*

Clevaland, Ohio 44106 ayN"

Dear Dr.' Castle:

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.gL hy This refers to your application to participate in the clinical evaluation q"-

of the Nuclear Dani-Stanicor No.184A nuclear-powered pacemaker.

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The implantation of nuclear powered pacemaker in patients is being licensed only' on a 11 sited investigational basis and until it can be established that:

(1) nuclear pacemakers are safe and reliable, (2) wide-scale use will not subject the public to undue risk, and (3) the benefits to be derived by patients using a nuclear-powered pacemaker will outweigh the risks, however small, to the public that might occur through an accident

~.M :c involving a pacemaker bearer or loss of the pacemaker to the environment.

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During the investigational phase of nuclear pacemakar use, licenses are s@.

.being issued only to medical institutions that can assure continuity of follow-up of patients with implanted pacamakars and not to individual physicians. The physician (s) designated in an application as a responsible investigator (s) should have substantial experience with pacemakers in

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.the specialities of cardiology and thoracic surgery, and the applicant medical institution will generally be expected to have an established w 4; 4'

program for the implantation and follow-up of cardiac pacamakars. A study team approach is emphasized. With reference to the above, your

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' application should be supported with the additional information listed

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List the cardiologist and surgeon member (s) of your study team and l,42 supply the following information on each physician:

(a) name,

,7 (b) office address, (c) telephone numeer, (d) state in which licensed to practice, (e) specialty board certification, (f) position

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with the applicant, (g) previous experience in the clinical implantation

and follow-up of pac =makars by the physician.

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8702260658 861021 REC 3 LIC70

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Form AEC-318 (Rev. 9-531 AECM 0240 A u E ' anv s..w =,...=te=e'erenc e se*>-e no

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Each physician member of your study team should indicate his j{0 adhere to it.

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familiarity with the Cordis Master Protocol and his comitment to

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Please submit a copy of instructions to telephone operators. This may be similar to Appendix H, page H-2 of the Cordis Master Protocol, but should be modified to include the names and telephone numbers of several physicians on the study team.

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It is not clear from your letter how the WATTS Line will be used for follow-up of pacemaker problems. Will you use it solely to keep in 9.h,.,

contact with patients and to answer inquiries? Or will it be used to Tis monitor the performance of the pacemaker? If you plan to use it in ggd the latter manner, how will you obtain the necessary information

$7; required on the Cordis follow-up form, specifically, determination C

that the patient is carrying his' ID card and faithfully wearing the

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approved jewlery?

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Your response to this letter should also include a statement of 4;.

concurrence by the Clinic Administrator or other individual authorized to make legal commitments for the Clinic..This statement should also include acknowledgement of the institution's long-term

,q comitment and responsibility for follow-up and recovery of nuclear

..s.Km pacemakers.

. ;I M-M' To assist you in preparation of your response, we are enclosing a guide for pacemaker licensing. Pages 5 and 6 are marked indicating areas of our concern.

M Please refer to Docket No. 70-2213 in your reply. We will continue our subsuem 3, - review upon receipt of this information.

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7gP Sincerely, N$$.

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. Patricia C. Vacca Radioisotopes Licensing Branch Division of Fuel Cycle and

' ?. t Material Safety

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Enclosure:

[.5 Licensing Guide (Marked) nf C.

cc: Mr. Norm Baker M.

'i[ff Cordis 210 Northeast 18th Street Nb.' Cress /MNBB B__

pc#003009 " "

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p Form AEC.M8 (Rev. 9-53) AECM 0240 W v s novan=n. ant enistime orrica. verswoo-ass

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