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 PAGE 1 OF ~2 PAGES' ts.e s)l, ' :li U.S. NUCLEAR RESULATORY COMMISSI;N'. ,
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Amendment No. 05 .
.MATERJALS LICENSE ;
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,
~
[ ,
l ? 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 In accordance with letter dated
, April 25, 1985 l
- 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 I Fort Wayne, IN 46807 _
- 4. p i n_ ate June 30, 1990
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- 5. Docket or Reference No.
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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 . l.
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jgder this license -
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A. Plutonium (Principal to y(. . Sealed source y l
- radionuclide'Pu-238P' p + {A.Onesourcenot.
to exceed 250 O milligrame [
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=B.' Plutonium (Princi T e 3.Onesourcenot
.,7 enns'Dedsourcef((,<
I radionuclide.Pu-2389 to ex eed 250
.s yp% j
,: m u-g y'f milligrams L
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.h 'G v2k 5e l'sourch ' / t- *%
l-i :C.: Plutonium (Principalp ~
h C. Two. sources not g
! ~ radionuclide Pu-238)' y iC.yhale~ Ty - ?,
Q to exceed 150- [
p l, \
yd .O milligrams l_
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- 9. Authorized Use '// y l 4 Kf l
[A. 'As:a component of Coratomic Model C'-10hnuileaho'Oered cardiac pacemaker for clinical ;_
- evaluation purposes. This license authorizes possession of'the pacemaker for purposes
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l of' explantation, recovery and disposal, but not for implantation. l l
iB. As a component of Coratomic Model C-100 nuclear-powered cardiac pacemaker for clinical I evaluation purposes. This~ license authorizes possession of the pacemaker for purposes
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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.
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-CONDITIONS L
10.. Licensed' material shall be used only at the Lutheran Hospital of Fort Wayne, Inc., l
- i. =3024 Fairfield Avenue,. Fort Wayne, Indiana. I b
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m _____________________ __________-_________-_____
] NRC Form 374 A W
U.S. NUCLEAR REGULATCRY COMMISSION PAGE 2 or 2 PAGES i
) ,, Lic;nse number N S ~
1 MATERIALS LICENSE . .
g,,,,,,,g,7,,,,,,,u7ber 1 SUPPLEMENTARY SHEET N l 070-01993 p i N
) Amendment No. 05 N J N
[ 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. p
] 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
- 13. The licensee shall report to.th t;e al i en in'g/ Branch, Division of Fuel Cycle 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. g
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j 14. The licensee shall contdnue patient follow-up and replacement b procedures for the E 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. $f E J
15.
f m3 m Exceptasspecificallyprovidedetherwiseby'thisgl$e O
f cnnse, the(l'icensee shall possess N
g and use licensed maderial describdd(inmitems ,fand8ofthiElicensein fp 1 accordance with st'atementsI,lfret i re'sintations, an (pro 6edur'es contIined in letter W 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 j Vice President; let l9/psignedbyjR'.E.Gil,liland; letter l g
j dated March 1,1977{it dated, August 4hg lT,amus;kMDj;$ letter ignedbygugust:N.r (dated May 28, 1980 g signedbyRichardE.{Cilliland, Senior 7Vice,' President; and letter dated April 25, g
]1 1 1985 signed by williarit(k Wissman,"In'terim Pjesidetst'. The Nuclear Regulatory y
] Commission'sregulation(shallgovern'th'edicinsee'$statEmettsinapplications n E or letters, unless the stftements are more restrictive han the regulations.
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} N l i 1 N j For the U.S. Nuclear Regulatory Commission p 1 N 1 N 1 N Original Signed y Dite May 31, 1985 By B.J. Holt i l Materials Licensing Section, Region III I l COPY p 1-- ----w mw === -- = =uaugr--mwousuut= = =mmmmmmermniR = = -s micu=udrer= ===d l
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