ML20129H541
| ML20129H541 | |
| Person / Time | |
|---|---|
| Site: | 07001993 |
| Issue date: | 05/31/1985 |
| From: | Holt B NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20129H545 | List: |
| References | |
| NUDOCS 8506070601 | |
| Download: ML20129H541 (2) | |
Text
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NRC Porse 374 1
~2 OF PAGES' ts.e s)l,
' :li U.S. NUCLEAR RESULATORY COMMISSI;N'.
PAGE
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.MATERJALS LICENSE Amendment No. 05.
Pursuan't to the Atomic Energy Act of 1954, as amen ed. the Energy Reorganization Act of 1974 (Public Law 93-438), and tie 10, I
L Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations [
^ heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct,
~
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? source, and special nuclear' material designated below' to use such material for the purpose (s) and at the place (s) designated below; to:
. deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). Thisi l
Dlicense shall be. deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is l
subject.'to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any I
conditions specified below.
l Ucensee l
l In accordance with letter dated
, April 25, 1985 f
- I' The Lutheran Hospital of
- 3. License number SNM-1551 is amended in its
? Fort Wayne, Inc.
entirety to read as follows:
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3024-Fairfield Avenue h
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p i n_ ate June 30, 1990 l
Fort Wayne, IN 46807
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- 5. Docket or 7
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G-Reference No.
070-01993 g-p
- 6. Byproduct; source,and/or
%f 7 Chemical and/or physical L8 Maximum amount that licensee i
h special nuclear material' form '
may possess at any one time.
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h jgder this license -
to y(.
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A. Plutonium (Principal
. Sealed source
{A.Onesourcenot.
y
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p
- radionuclide'Pu-238P' p
to exceed 250
+
j O milligrame 4
g enns'Dedsourcef((,< 3.Onesourcenot
=B.' Plutonium (Princi T e
I radionuclide.Pu-2389
.,7 yp%
to ex eed 250 L
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y'f milligrams I
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t-5e sourch h C. Two. sources not i
- C.: Plutonium (Principalp iC.yhale~ Ty -
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Q to exceed 150-
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g
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~ radionuclide Pu-238)' y yd
p
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milligrams l_
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- 9. Authorized Use
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[A. 'As:a component of Coratomic Model C'-10hnuileaho'Oered cardiac pacemaker for clinical
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- evaluation purposes. This license authorizes possession of'the pacemaker for purposes l
of' explantation, recovery and disposal, but not for implantation.
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iB. As a component of Coratomic Model C-100 nuclear-powered cardiac pacemaker for clinical I
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1 evaluation purposes. This~ license authorizes possession of the pacemaker for purposes x
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' of explantation, recovery and disposal,' but not.for implantation.
[
C. As-a component of Moderonic Model 9000 nuclear-powered cardiac pacemakers for clinical l
L Tevaluation purposes..This license authorizes possession of the pacemakers for purposes l
.of explantation, recovery and disposal, but-not for implantation.
l
-CONDITIONS 7
L 10.. Licensed' material shall be used only at the Lutheran Hospital of Fort Wayne, Inc.,
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=3024 Fairfield Avenue,. Fort Wayne, Indiana.
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NRC Form 374 A U.S. NUCLEAR REGULATCRY COMMISSION i
PAGE 2
or 2
PAGES
) W Lic;nse number N
g,,,,,,,g,7,,,,,,,u7ber S ~
1 MATERIALS LICENSE.
1 SUPPLEMENTARY SHEET N
l 070-01993 p
i N
)
Amendment No. 05 N
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[ 11.
The specified possession limit includes all licensed material possessed by the
.y licensee under this license whether in storage, implanted in patients or otherwise g
j in use.
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N I 12.
The licensee shall report to the Material Licensing Branch, U. S. Nuclear Regulatory N
1 Commission, Division of Fuel Cycle and Material Safety, Washington, D.C. 20555, N
within twenty-four (24) hours of occurrence, the death of any nuclear pacemaker j
patient, and any adverse reaction and/or malfunction involving a pacemaker system, y
J including the leads. A written report giving details of the adverse reaction and/or g
]
malfunction shall be submitted within thirty (30) days.
p i en in'g/ ranch, Division of Fuel Cycle
- 13. The licensee shall report to.th t;e al B
j and Material Safety, U. S.(Nu'eleYr Regulatory Commission, Washington, D.C. 20555, l
q within ten (10) days, lo of contact with a nuclear pacemaker patient.
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j 14.
The licensee shall contdnue patient follow-up and replacement procedures for the H
1 nuclear pacemaker during theslife of the patient. Procedure's*for recovery and H
1 authorized disposal ifM the' nuclear pacemaker by retur'n to thedanufacturer shall be N
1 followeduponthedekthoftheMatient.
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Exceptasspecificallyprovidedetherwiseby'thisgl$e cnnse, the(l'icensee shall possess f
15.
and use licensed maderial describdd(in items
,fand8ofthiElicensein p
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accordance with st'atementsI,lfret re'sintations, an (pro 6edur'es contIined in letter W
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l dated April 21,197~5) sign" eddy kJan}ButWTAs'sistadt,V'i'ce;PresTdent and 5
AugustN.Tomusk,H.D.;leitei;/d8ediJUtEe) 24,[197'5~ sik,ned[byEKDanButz, Assistant l
dated March 1,1977{it dated, August 4hg lT,amus;kMDj;$ letter (dated May Vice President; let l9/psignedbyjR'.E.Gil,liland; letter g
j signedbyRichardE.{Cilliland, Senior 7Vice,' President; ignedbygugust:N.r 28, 1980 g
j and letter dated April 25, g
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1985 signed by williarit(k Wissman,"In'terim Pjesidetst'. The Nuclear Regulatory y
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Commission'sregulation(shallgovern'th'edicinsee'$statEmettsinapplications E
n or letters, unless the stftements are more restrictive han the regulations.
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For the U.S. Nuclear Regulatory Commission p
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Original Signed Dite May 31, 1985 By B.J. Holt y
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Materials Licensing Section, Region III l
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