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t 4 841                                                         U.S. NUCLEAR REGULAVORY COMMISSION                                           PAGES MATERIALS LICENSE                        Amendment No. 02                 g k Pursuant to the Atomic Energy Act of 5954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations                   p heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct,     g I
g NRC Nm m
source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to       g I   3           deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This       i license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is '               E subject t'o all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any
~
              . conditions specified below.                                                                                                                     g U'*"'"
PAGE-OF PAGES 1
In accordance with letter dated
2 R
      $                                                                                                March 17, 1986                                           h 1
4 841 U.S. NUCLEAR REGULAVORY COMMISSION t
: 1. St. Luke's Medical Center                                                 3. Ucense number   SNM-1638 is amended in l                                                                                               its entirety to read as follows:                         llI i
Amendment No. 02 MATERIALS LICENSE g
s                                                                                              ,                                                         W t 2.
k Pursuant to the Atomic Energy Act of 5954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations p
(>,gr ,* Q,3 2900 West Oklahoma Avenue I                      Milwaukee, WI 53215                                                          c k',r2tiop6
heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, g
                                                                                                  . 4.Mp   'f        ate      February 28, 1993 E
source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to g
p
I I
3 deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This i
license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is '
E subject t'o all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any
. conditions specified below.
g U'*"'"
In accordance with {{letter dated|date=March 17, 1986|text=letter dated March 17, 1986}} h
1 llI 1.
St. Luke's Medical Center
: 3. Ucense number SNM-1638 is amended in l
its entirety to read as follows:
i s
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(>, r,* Q t 2.
2900 West Oklahoma Avenue
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. 4.Mp February 28, 1993 p
I Milwaukee, WI 53215
: 5. Docket or
: 5. Docket or
    !                                                                  %q e                          Reference No.       ,
%q Reference No.
070-02205                         g.
g.
1
070-02205 1
e
: 6. Byproduct, source, and/or
: 6. Byproduct, source, and/or
                                                                      ,p*         7. Chemical and/or physical           L( Maximum amount that licensee         5' i special nuclear material                                       form -                           n $may possess at any one time           E
,p*
      %                                                            Ga) f,e VN                                    fy /       ' dader r
: 7. Chemical and/or physical L( Maximum amount that licensee 5' i special nuclear material form -
thislicense               N 5
$may possess at any one time E
A. Plutonium (Principaid                                  s g ,.>S,ealed       Sources'4 ,n/
n Ga) VN f /
                                                                                                          ', (
' dader thislicense N
A                                                                          k-I                                                                                                                  g*4.50       grams sourc individual    (20 s radionuclides Pu-238')'
f,e y
6' M[1?t Q ) Qg'Q
5 s g,.>S,ealed Sources'4,n/
                                                                                            /   /     i         <3               C,nottoexceed22                 lg H        (M"Mq?(fAMA j f/
g*4.50 grams (20 k-r A. Plutonium (Principaid M[ Q )Qg'Q
gh                     b gg ,/,
', (
                                                                                                                                  - milligrams each) q                             g y  .
individual sourc s A
                                                                                                                                                                      )
I radionuclides Pu-238')'
ss
lg 1?t
: 9. Authorized Use                           QJ                         W$           ef       U   -        %                                b Implantation in huni5ns                               4 p n5nt'    a%jcom,W~o%       ,1 y lgl      lcC
/
                                                                                                                                        .                          E A.                                                    Pa                         o isNucleafOmni-SkanicorModel184A                         I E
/
nuclear-povered caFdiac                   v, pac'emak'eVsifo@Welitiical W 9                  l3 ,y ebluation                 @u,rposes.
i
                                                                                              ,                           fu                                   l l     '
<3 C,nottoexceed22 6'
y/} ,                  CONDITIONS
(M"Mq?(fAMA j f/
- milligrams each) y gh b gg,/,
q g
)
H
: 9. Authorized Use QJ ss W$
ef U
b Implantation in huni5ns a%jcom,W~o% lgl.
o 4
,1 y lcC E
Pa p n5nt' isNucleafOmni-SkanicorModel184A I
A.
E nuclear-povered caFdiac pac'emak'eVsifo@Welitiical ebluation @u,rposes.
l v,
W 9 l3
,y fu l
CONDITIONS
* if
* if
                                                                                                                      -( y\                                       j
-( y\\
                                                                                                .o e                                                           p
j y/},
: 10. Licensed material shall Telbsed only at St. Luke's Meficil Center, 2900 West Oklahoma                                                 k Avenue, Milwaukee, Wisconsin. q                                                                                                       i
.o e p
: h.                                                                             V 4 , 4 , k Mg                                                             lp g            11. The specified possession limit incitides*hil?1icensed material possessed by the                                                             ,
Licensed material shall Telbsed only at St. Luke's Meficil Center, 2900 West Oklahoma k 10.
licensee under this license whether in storage, implanted in patients or otherwise j                                                                                                                                                                g   l i                         in use.                                                                                                                                 E E
Avenue, Milwaukee, Wisconsin. q i
: 12. The licensee shall not receive or transfer in any single transaction, 1 gram or more                                                     E of plutonium-238 contained in nuclear-powered pacemakers without notifying the Division of Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555,                                                   g l
h.
l             and, in addition, completing and distributing Form NRC-741 as required by Section                                                       y i        ,
V 4, 4, k Mg l
70.54 of 10 CFR Part 70.                                                                                                               g l       @                                                                                                                                                        E I
j The specified possession limit incitides*hil?1icensed material possessed by the p
J
g 11.
: 13. The licensee shall report to the Material Licensing Section, U.S. Nuclear Regulatory                                                   B q                 Commission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 24 hours of                                                         E y                 occurrence, the death of any nuclear pacemaker patient, and any adverse reaction                                                       ly and/or malfunction involving a pacemaker system, including the leads. A written report giving details of the adverse reaction and/or malfunction shall be submitted                                                   g within 30 days.                                                                                                                         R 4                                                                                                                                                 f g<     ,
licensee under this license whether in storage, implanted in patients or otherwise g
f aw COPY I
l i
w         -
in use.
e903070218 080201 1_-_--.                                                                                   a
E E
: 12. The licensee shall not receive or transfer in any single transaction, 1 gram or more E
of plutonium-238 contained in nuclear-powered pacemakers without notifying the l
Division of Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, g
l and, in addition, completing and distributing Form NRC-741 as required by Section y
70.54 of 10 CFR Part 70.
g i
l E
I J
13.
The licensee shall report to the Material Licensing Section, U.S. Nuclear Regulatory B
q Commission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 24 hours of E
y occurrence, the death of any nuclear pacemaker patient, and any adverse reaction l
and/or malfunction involving a pacemaker system, including the leads. A written y
report giving details of the adverse reaction and/or malfunction shall be submitted g
within 30 days.
R f
4 g<
f e903070218 080201 COPY I w aw 1_-_--.
a


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p- ic                       Iorm h74A                       U.S. NUCLEAR REGULATORY COMMIS$10N                                   2 OF
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( N5                                                                                                                      PAGE            2 PAGES N
(
* License numbn                                 l l                                                   MATERIALS LICENSE                                 oocket or nererence nurnber SUPPLEMENTARY SHEET 070-02205               g Amendment No. 02 l                           14. The licensee shall report to the Material Licensing Section, U.S. Nuclear Regulatory                             l f                                   Commission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 10 days, loss of                               i I                                   contact with a nuclear pacemaker patient.                                                                       R t                                                                                                                                                     l l                           15. The licensee shall continue patient follow-up and replacement procedures for the                                 l 4
N5 U.S. NUCLEAR REGULATORY COMMIS$10N 2 OF 2 PAGES PAGE N
nuclear pacemaker during the life of the patient; and procedures for recovery and                               i n                                   authorized disposal of the nuclear pacemaker by return to the manufacturer shall be                             g i                                   followed upon the death of the patient.                                                                         I e                                                                                                                                                     B     1
* License numbn l
: 16. Except as specifically provided otherwise in this license, the licensee shall                                    I
l MATERIALS LICENSE oocket or nererence nurnber SUPPLEMENTARY SHEET 070-02205 g
Amendment No. 02 l
14.
The licensee shall report to the Material Licensing Section, U.S. Nuclear Regulatory l
f Commission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 10 days, loss of i
I contact with a nuclear pacemaker patient.
R t
l 15.
The licensee shall continue patient follow-up and replacement procedures for the l
l 4
nuclear pacemaker during the life of the patient; and procedures for recovery and i
n authorized disposal of the nuclear pacemaker by return to the manufacturer shall be g
i followed upon the death of the patient.
I e
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j                                   conduct its program in accordance with (the statements, representations, and                                     l       .
16.
e                                   procedures contained in the do'cuiferWs i"nbludinglany enclosures, listed below.                                 b I
Except as specifically provided otherwise in this license, the licensee shall j
;                                    The Nuclear Regulatory Condi.sst6n's regulations'1hal,ingovern unless the statements,                           I     l representations and procscdres in the licensee's application and correspondence are                             1     l more restrictive thartlbtSe regulations.                                       #g a j
conduct its program in accordance with (the statements, representations, and l
y                                                                 m                                                                                    I g                                  A.      Letters dated( 6Febroary'               4,1976, May 10,1976, May/-27fj$981andMarch               17, 1986.
e procedures contained in the do'cuiferWs i"nbludinglany enclosures, listed below.
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l representations and procscdres in the licensee's application and correspondence are 1
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Latest revision as of 04:22, 3 December 2024

Amend 2 to License SNM-1638 for St Lukes Medical Ctr, Amending License in Entirety
ML20235S676
Person / Time
Site: 07002205
Issue date: 02/01/1988
From: Matson E
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:
Shared Package
ML20235S679 List:
References
NUDOCS 8903070218
Download: ML20235S676 (2)


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4 841 U.S. NUCLEAR REGULAVORY COMMISSION t

Amendment No. 02 MATERIALS LICENSE g

k Pursuant to the Atomic Energy Act of 5954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations p

heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, g

source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to g

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3 deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This i

license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is '

E subject t'o all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any

. conditions specified below.

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In accordance with letter dated March 17, 1986 h

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St. Luke's Medical Center

3. Ucense number SNM-1638 is amended in l

its entirety to read as follows:

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2900 West Oklahoma Avenue

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6. Byproduct, source, and/or

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7. Chemical and/or physical L( Maximum amount that licensee 5' i special nuclear material form -

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CONDITIONS

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Licensed material shall Telbsed only at St. Luke's Meficil Center, 2900 West Oklahoma k 10.

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j The specified possession limit incitides*hil?1icensed material possessed by the p

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licensee under this license whether in storage, implanted in patients or otherwise g

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in use.

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12. The licensee shall not receive or transfer in any single transaction, 1 gram or more E

of plutonium-238 contained in nuclear-powered pacemakers without notifying the l

Division of Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, g

l and, in addition, completing and distributing Form NRC-741 as required by Section y

70.54 of 10 CFR Part 70.

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13.

The licensee shall report to the Material Licensing Section, U.S. Nuclear Regulatory B

q Commission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of E

y occurrence, the death of any nuclear pacemaker patient, and any adverse reaction l

and/or malfunction involving a pacemaker system, including the leads. A written y

report giving details of the adverse reaction and/or malfunction shall be submitted g

within 30 days.

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  • License numbn l

l MATERIALS LICENSE oocket or nererence nurnber SUPPLEMENTARY SHEET 070-02205 g

Amendment No. 02 l

14.

The licensee shall report to the Material Licensing Section, U.S. Nuclear Regulatory l

f Commission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 10 days, loss of i

I contact with a nuclear pacemaker patient.

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l 15.

The licensee shall continue patient follow-up and replacement procedures for the l

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nuclear pacemaker during the life of the patient; and procedures for recovery and i

n authorized disposal of the nuclear pacemaker by return to the manufacturer shall be g

i followed upon the death of the patient.

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16.

Except as specifically provided otherwise in this license, the licensee shall j

conduct its program in accordance with (the statements, representations, and l

e procedures contained in the do'cuiferWs i"nbludinglany enclosures, listed below.

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The Nuclear Regulatory Condi.sst6n's regulations'1hal,ingovern unless the statements, I

l representations and procscdres in the licensee's application and correspondence are 1

l more restrictive thartlbtSe regulations.

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Letters dated 6Febroary' 4,1976, May 10,1976, May/-27fj$981andMarch 17, 1986.

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