ML20153D090
| ML20153D090 | |
| Person / Time | |
|---|---|
| Site: | 07001209 |
| Issue date: | 08/08/1991 |
| From: | Swanson C MEDTRONIC, INC. |
| To: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| Shared Package | |
| ML20153C940 | List: |
| References | |
| SSD, NUDOCS 9809240307 | |
| Download: ML20153D090 (5) | |
Text
m a,,.-...
h h
W )v hhhy. W 'f N $ Y f?$WW &b'W #5 MM6dtroriic EWDl.7 A t t a c@hme n tt 2 S n'.w N 6 'W k k Y ?l$ Q. %@ 4 &
O h" W3 i " Dlganen;QWTM M
pM A@M)'v ji'QMy% T
, $ p@Augu tjl8jf(. W i W k,$, N g p
MM. ;$W M'nneapou MN
. W. %
55432 3576-., V.F ff Y
W.. $' Cable. Mes:ronic. Telec M C Te'ephone: (612) 574 4000
.j h
e 1991 W 00 p y%. pp M c y n 'e 1.s w A M, M,M, @:
NW s
1
' " ; ; Telecopy; (St2) 574 4079
.;7 a y
,N, 4
0.g, Q y 90.- A TF y n; q 8/iWWia.0 2/ R u e J'
w.
hgg N
.c n
O s.
7-
, %s w,..
, oace
,y r
, a. np w' n. n M.:3,.ym Qq j ;,,.3:
wp v,
s,
.e mM...p y v e rM tN.W
. p :. s Q V;n.
vc,m "6, ~
' ph{W(pc t u ;t a
s-w, s
' -W se ~ >
,.~
,,5
- N'l.:.
A cdh a
Attention:'l Materials"Licen$1ng'Se'ctioni[
. A; j; U.'S 4 Huclear, Regulatory: Commission; o{;.,
.y
/
h%y 7
g
-(
('
.[ G s
h Reii'onM3'.N
.p,'
l'.
y J
' a;c
. j @ pan @7 Glen Ellyn/?ILL 60137K ~ ?q vm:'
7996 Roosevelt.tRoad'
.s Q: 4-
, y, G.
g
- 9.h, 3 a V' ii.p NQ
. $h]%2n,M.
k J 5k'.c
- b N.
'li o
4,:. Q Y
.y
..?
% k ekt{lemenk?. N.L!. $ O W.
't
'h b.h
%5]W::r:9,i v"
?
g"g$
g;gTheqpurpose 'of'.thi(s ' letter.'isltoL appl'y for renewal c'f License y~
I E
7 g% VS.Agp(SNM -1156 7 initially granted > September <
30,,'1969...This license l g.. 'ib e
' W @ ' b.
$yd ql,/,y expires June 30,n1991.n.Information~for, license renewal'.as%Mkspecified L-
'[
T h.bMphWbelowcorincorporatedibyreferences'tothelicenseand
~
V'
~
hh95MMy' amendments. A Seven : copics,ofl this : licence renewal ~ application :are.
i 3:
iW l
d.'.
4 y$m umpenc ose 3
m hrg,i a.m #n o,r
- m. :
m gQ;dp;.A;. c 1)n -. i(. is 4'
Applicant v.
,n m.
p r
n
'd. '$;$wh M:*[MedtroniS,'I'nc.
' i
. w+
gMp%%?%
& '(7000 Central Avenue, N.E.
i p $i W Minneapolis,+, Minnesota 55432 p,
,}M &n i %@g./ WHedtronic,
.C.*
4
'. ~
Mf6 L M n: 'q w' g
Inc.t is' incorporated'in the State of Minnesota M
9
~<
alp;iSA
?,lvith'CorporatesMeadquarters at-the' address listed above.
p g a l y. w. :. Ww$ a d d r e s s e s a r e a s ' f o l l o w s :
+
p o
m
, ~W, h y.m Principaljofficerstof.the Corporation =and their residential-l d.u)
$,,. ~t l~$ j m,
M 4
l hM[%gg<,[. 7 l4 gt..i pt.c
.N~
l
$se
...p j,: ;
. t.
s.
l.
$EarlcBakken <
.c"'Willard Lewis,
{
q:
g ' $, N.5l0 c
' h Q.p%~, m.f.'f15424 West Bavarian. Pass l 32031 Via Oso
.il l
hMinneapolis,fmt 55432,-
'j' l
- ,wTrabuco: Canyon, CA 92679
,4 g
.w.
i "t,.,.
'/
1" mem
- , r
,3 s
i
- i p lQ X O N111am Chorske' 1
'c Ronald Lund e
MQM 2270 W. Lake of'the: Isles Parkway ! 5565 Waterford Circle c
hl
, M,w,$ 'T K /, 3W, %,. ~Q.N. YMinneapolis,,MN 55405'
' Shorewood,'MN 55331-2 s ;., ;v>. y,.:.-
p% e W G wf'.
- Bill 1Erickson..
K
John'Meslowi
.Ol s
kkhD.'M$'6000Wyngate Lane?
T '1386VKnollwood Lano O
DjfMIM Mendota Heights, MN 55118 J,,
km y gn 2 MMinnetonka,1MN;55343 f
<a.
wh;;.
hkMfWillia'm f
corge 1
iGlen. Nelson.
D'
.hpi 2284+WQ Lake of;the' Isles Parkway.1500 Tonkawa Road
.y
' h f :) $y. h, 4 0 :
! h3fp% M Y b X,
i.
-lLong Lake,,MN 55356
%y k Minneapolis,L MN.55405,
+
4 h ',, M '+
t'.
l
- p.,
%. M bop GEiffinl '. c.
' ' 'Q
- M N M h $ h1326
- Spring'ValleylR'oad.
,;3Gerard P1anchon.
>:4701" Golf Terrace
$ r.h.y.il$h:FMw u -';f : M M. Golden;Vallsy,4MN;55422 Edina, MN 55424 g$f t/ N #,d LowelltJacob'sen.,
i
- g. p x,.
~
Winston Wallin w
4
! % $ d ^, N 6750'Olde Sturbridge 7022 Tupa Circle I h..v.,.E / ygh,Hamel',;MN 553 4 0 Edina, MN 55435
,L
" QD%jk:
W W'
e m.v.e, %
.g
_.;;g3 9,y. y('
i 9809240307 980916
'"~
+
'o
- 1 PDR RC SSD pop v
?,;.
$NN@tf'9 g ~
l' h.?
l 4 Q N y g h.;[*%', [:(h M W V 6
+ 7., y m-
,b 7
- p":
e V
y,
~*
( n'g l:kg, .
c' A
b M..*Q' v
- Oith,'the exception"of[Mr. Gerard'Planchon who'is a citizen T
q
~-
, y,1 QMl.[:, 4 C,
'of-France, all. principal: officers are U.S.
citizens.
VgX. &
- 9 I
,lhM' Notcontrol or controlling stock ownership is exercised over I[
t
< ' #.' ' s
. l", '. government.
g t
.Medtronic,.Inc.-by any alien, foreign corporation or foreign-j.p.
l g#(x '. i w,
t r a
1
.Netivity'for Which the Special Nuclear Material is Recuested!
b'
! IME hC,
i 2 )
4, JMq.; (:"y,, r. '7' Scaled plutonium,(PU-238) sources are used as a power cource l:
95,'s forca cardiac. pacemaker, specifically the Medtronic' Model
,i.
yQ @", ---~e 9 0 0 0.,Modtronic, Inc. no longer manuf acturers or sells -
phl c,
L nuclear. powered cardiac pacemakers.
License renewal is -
f.;
', requested for the possession of scaled plutonium sources.
ft4 ',.. r l
,d
/
' where.the primary activity is associated with the receiving, l f[y,i,y '
j
,: analyzing and storing of explanted pacemakers.
No tests or i
l
'?.
s
- other activities will be performed that will in any way 9.'[ },,!
l s
'compromisc the containment of the encapsulated plutonium
' ;g,4 l
source.
r.3
):
As described in our' license (SNM-1156) and amendments, l
analysis and storage of scaled nuclear sources and nuclear l
hlc '
powered cardiac pacemakers will occur at the following
~
l i h.
locations:.
h
' h'!
IRice creek Facility Wx 7000 Central Avenue, N.E.
l s
I f4[
Minneapolis, MN 55432 l $.P. o l Qff
. Physiological Research Laboratory W ( ',,
Division of Medtronic, Inc.
M:', -
1385-115th_ Avenue, N.W.-
n l
Minneapolis, MN 55433-
-j
( p{(,k k
Also,.as described in our, license and amendments, we are l hf,.,
allowed to store one Medtronic Model'9000 pacemaker at cach a
of seven of-our District Offices.
This was done to minimize
,y (g %,fi.Vi
' delays and uncertainties in shipping these pacemakers to J'
"'V V
physicians and their patients.
Medtronic wishes to retain l
['
storage capability at the District offices listed below to y
provide a way-station, if necessary, in the return of l
j',
explanted nuclear pacemakers to Medtronic's facilities in prg,l' Minneapolis.
The District Offices are:
, y.d:.
Medtronic, Inc.
i.
l h },
- [: 10 Executive Place V, Suite 204
~
5 4
60 Mall Road b* >
Burlington, MA 01803 l J&.
Medtronic, Inc.
1 Summit Square, Suite 102 AM[h/:,
Langhorn, PA 19047 6Aq[
M
- c...
.,G
! gM.n.
gx-
-=========maar--.-m.m-.,_._...,,,,,_,,,,,,.,,_,..,_,,,_,,,,,,_._,.__.,_;
!b.
.b
,h'(
ha!Ni[ 'I, % ' ' T ' ', U:t s ', i. 'd$
~
i i
.P
%.,g, : % " ~
p/.p%y[,'.f..
4 Medtronic, Inc.
i!
p J
a, A(glc,:;p...
m
-1911 North, Fort Meyer. Drive, Suite 804 tl
-l, v,
- L J fp;CW"z,.
- 2. Arlington, VA 22209
'?
1
?7NM j.-
@..7 s
i M e d t r o n i c, v.'I n c. '.
.dl
@M%y,f,h;1'j' s
lM t,
4' 255.' South Woodward Suite 202
'\\'
j.j:/7.' h
..o,-Birmingham',..MI 48009 a
- s. c
,.n W
w4:,JMlW, ii'
'o Q W;:
J M c'd t r o n i c,., I n c..
WM!@N Llv f4
4700lRockside Road,~ Suite 408
?. V 1
Gh.ylK.
? Independence,.'Ot.44131 c,
.o.
. ;..:q p..,g v
.,~.,
n
. :l,
p:p #
?Medtronic,;Inc.
,;';: ;f 11 East 22nd. Street, Suite 407 2l
^'
N. '.M; 4
'Lombard, IL '6014 8 -
E ~'
9 4
kedtroriic *
~.n.
Inc.
w-g.$;, ' _.
- lli Westport Plaza, Suite 1015 W lJI
- St. Louis,,MO 63146
,s
~
X,,@,4 p 13)7 ~ Time Period of' License
- ' - o
,.1,.
- [p.-[',
- License' renewal is requested for.a period of five (5) years C. %q.s.
through. August' 31,.1996, t.n,3.a,,
.s c;; 7 < 'v4)
Nase,'Amound and Specifications of Nuclear Material ox.-
. % N,,,-
238
.A l The' plutonium sources (Alcatel-GIPSIE)'contain Pu as the
'l.
principle isotope.
Possession limit under license SNM-1156
- @ $. I '
is 125 grams total'with no more than--1. gram Pu per source.
23s f.lP 3a.W..
-It :is requested that this. limit be continued.
hi
.s s
D,
. f. '
~-Detailed information:with respect to the' chemical and
.Wil ~ s
.fphysicalEform.of plutonium sources has-.been supplied 86.%; 4l(
'previously under, license SNM-1156 (Docket No. 70-1209),
6 /,. G i,., '
Oualification of 'A$olicant.
'\\
.%% ',. 5 ).
- $ b,.
EC.7 M'"[.~
MedtronicIhas:had~over sixteen years of experience:in the
$$2,
" 3'lJdesign,. manufacture andjtesting of implantable nuclear My.i
.N ' '
? powered. cardiac pacemakers.
J me
- U
~
4NU.
IMr./ homas Hawkinson is the Radiation Safety' Officer for 4
T M' ' A
- -Medtronic.
His, qualifications are provided in Attachment 1.
,;& g;;
A
~
'? Current' members or tho' Radiation Safety Committee are as
$fMN,". V
>follows:. Thomas HawKinson,; Chairman and Radiation Safety
$i
- officer;scharles Swanson,'.Ph.D.,. Director of Regulatory
$"lt n ~. ?
rlp M.
- Affairs; Dale ^Staffanson, Manager of Product Analysis; and E
I**
LGail;Zimmerman,'Ma' nager of Configuration Assurance.
Op,Gj -
,1 li \\ < G,l
.&.%.I Gl; m.
- s
- ~.: i r, Q.', vf,.
{.% 2"
';M)n L '.\\.a):pgi
}l
&,ph&y.S,.d;,f..' ;f u ;> '
WQ n.,
i i-a:.
'p m
M.,
h; N
(; f e y $ h t
.m
,m w;,IY;q.. sipUnh, All'Me'dtronic. personnel; responsible for the' handling;and~
v r.
J;hQ n
' testing' of sealed: nucleare cources and nuclear powered.
+, l
'l)'n6[ij<h !
. pacemakers ( have been instructe'd':in. proper handling and '
,.J.
d Im$n,i. ',j:
storago1 procedures.as. required by ourfLicense (SNM-ll56).
- l
'MJ.P tMi, W 6 ).
<J
,,r s i
-(Eculomont and " Fa'cil'it ies. ',,
- gy ','
ht%'[y S 9:
@M Facil'itiesjin~.which/ sources'are.heldIandlcquipment used in-
g I
lin.%'%ik
' / monitoring-and. measuring are. described in-Licensu SNM-1156'
.c.
.. J;;.Ic.(.ylfmU '
U
@ :o
.and. amendments.s 4
r
',1!Ph' (y a I
-" k.
.L7).
Procedures to Protect Health and Minimize Dancer s -.,
n ;p %
~
g.. i a
~ Security.precauti.,ons and monitoring. procedures to protect d/4
- health and minimize danger to life or' prop'erty are described
'.. :q
.in License SNM-1156 and amendments.
W e.
r e
..h.
a check!for'$550:is enclosed as the
'As requirodiby.10 CFR 170, 4'
- 9
&.l 'n renewal. fee for this licence renewal. application.
3.; '. is.
ci W,:p,.i '
Communications.with.rcspect.to'this application for license
,l 'J MT irenewal should be. directed to Charles H.-Swanson,.Ph.D., at the 5.i telephoncinumber listed below.
v/m.
oc, -
.i nL"4.',. Sincerely,:
- q
- M,,, '.
', 0 MEDTRONIC, INC.
4 2
(,).
l76< ^
&s,i:0 thar16s H.
Swanson, Ph D.
p..,,;h, '_,
. Director,. Regulatory ~ Affairs s
J:'g Cardiac, Pacing Business f -(612) 574-3409-
- 5....
- y, %:.:X_,0, lCS3/1712C5f g
,7.'. & q.;
ftM,!. '
. Attachment
. v, c s
$f' '[~
.g~
hI,
f.).?l{ '
gg. y -
.t*
[;Y_^ e QO:s
!$p f ;
.$sm.sp
^4.-]
%.Ys t tn*
g g,.-
.yf
<c '
8 5
f.';f *',/] :s t
{.,
e 1
a.i',
wm.
w$.. y;p,J.$ t h $ w; g i M p 4 W M h m W M g g. W a W' F, p w M,. ~
'. + M. e. ;%q I
Weg.g<e ry. %. 5,9
.t d,.. v..e %cu...: n, v,. r. a, n. u y y;,.t w e W.. ~, M,,,
,,.. a.
n y
-aYy
.$.$$$4 CONVERSATION [ RECORD' '" s w
- , j g. 9,/ ;
's s:
1
?' -. TYPE;lg., g -
f, N
VISIT q,7;d.> y i N,a 5 Q, c O CONFERENCE.,',
' 7 ELEPHONEi,*
(t
,. o t..,,u# p,,.,u.l d, V 'h,,,,., A.
r nouTINQ
.,m f
l DWi
-y
- D INC',OM' ING o'."#
i, yt HAWc/5YMBOL INT j
n ;.
p w
s #'/
6/ 2 -
8 g$$g$$ N % C y W R S b % M &.0,
'"4-S.hch 57'/ ~. Nod k
...//[g, _dg.,, /,,g.gf [.,,
- lN
~
);g.7;ica ('.Ms c N. W w sus;EcT
,fp
'? W 2 s
j Apv igff dkz.. mla:e ' '-
a.
- .a i
- , ~
.^.
. ^ -
f-f 2:w e
SF f,,.L f h ('l' ',?. Qy,h j,
,g
~Q/))/
s% %. p ' N f d M f 4 4 W W # % w M x M bj Q lg (
4
" 'J 4/ V 0
o k
$Y.. r w ~7}b.d $,
0 h e
A W so%?$ev al Le 2/lzas" ~ Z!). l' i
jh 4
in w w ~
- 3'
% A 4 M 4. W.
~
i v a. W.~.Mh g
a a.
lg 1 r 1
. j u M LL A & J f f i w.n gn&
Q@%DM Ws,wM,a 3nya m;L(,&,Q;f._
g 4
p 1
h.,%sW;$,2 $M W
~^
CI
'N w
p gy *-
N l }
w 6
p & /pc l
j[jhhj f
)&
if M
ln$ M 72,.,A/x &,. S k h. d W Q ;
'Y ' Y, hk.J hQ
,, f 4 h. bl j f,g y d k
~
h M A % M dg' [ D bb3" 7 2 d
/223 9
g$g%g, k23 map w[a ~ig gp %
gnaagg
.ug
/
py wun,sgs
=
NN@ ACTION MEQUIRED//[ "p%;
./
m f-C Ql vy :..Vah b ; *,T ". ' ' L ;
l, i
f g}(5.h;.%. <
- e 5.9;T4 W'
'~N
, a' f%o&hlf.x, Auc or..Ptoo~ occuve~Tmo co~msuio~.
sic ~uu a c.
occ a
l# -
.m lb [ -f
.f,' ACTION TAKEN W,
___/
p w; -)_, _
4! ' 'g V
) W,:w + _c ;,
i r
Q, n,Mp., '? lm.1 y $;gM:
4 M,cucunc ;
Tittc onc 6
h hh;r'.'t:
1 p
' f,X
- ~'* U "N ~}, -
CONVERSATION RECORD -
.. Qf,",^JgG"o",38,4 g').- ',
, ' h 4,5.
[:
8:
. {Y('h 9 m',7 ' +?
?
.m a xi.
s' p 7 g
- c
' ?>
i' ' ' ' e %5'-', Y Y
E'.
0 N'
's
^*
- ~
e r-.-
+ - -
.-r.-
-