ML20153D070

Matls Licensing Package for Amend 21 to License SNM-1156 for Medtronic,Inc

ML20153D070
Person / Time
Site:	07001209
Issue date:	12/27/1991
From:	Hueter L NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:
Shared Package
ML20153C940	List: ML20153C937 ML20153C964 ML20153C993 ML20153D009 ML20153D021 ML20153D042 ML20153D051 ML20153D070 ML20153D090 ML20153D104
References
SSD, NUDOCS 9809240298
Download: ML20153D070 (5)

Text

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) lq ((HRC t o-sn .: FORM 374 ;

' O.S.' NUCLE AQ REGulA70RY COMMis$loN Q #d l #

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Amendment No. 71 MATERIALS LICENSE

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+ (q '. Pursuant to the Atomie Energy Act cf 1954in amended, the Energy Reorgani/ation Act of 1974 (Public 1,aw 41.btL and Tiite 10 )

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,h ( '_ Codd of Federal Regulations. Chapter I. Parts 30,31, 32,33,34. 35,39,40.uwt 70. arwl in reliance on statements and rer:esentations heretoliire p p I i male by the licensee, a licenw is hereby inued authorii.ing ihe licensee to rectne, acquire. guuen, ;;nd trartsfer byproduct source, and special P

@ 4 nuclear material designated below; to uw such material for the purposch) and at the plaech) dedynated below; to dehver or transfer weh roaterial h N N

. to persons authorised to receive it in accordance with the regulations of the applicable Panb). This license shall be deemed to contain the coewhiions k h  ; specified in section 10 of the Atomic Energy Act of 1934, as amended. a nd is subject to all applicable i ales, regulations and orders of the Nuclear f g 1 Regulatory Commission now or hereafter in effect and to any conditioni speoned below, p ff (,7 >

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$- 4 Q 'J In accordance with letter dated August 8, 1991 '>

W 4 J 1. Medtronic, Inc. 3. tjcense number SNM-ll56 is renewed in its kl entirety to read as follows:  !>(

! [2. 7000 Central-Avenue N.E. --

$: 4 -Minneapolis, MN 5543? 4. Expiration date December 31, 1996 s ( _ . . . _ _

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070-0 P09 N y

, ( Reference N.o g 4 6. Byproduct, source, and/or 7. Chemical and/or physical 8. Maxunum amount that beensee F 13 i -

special nuclear material form may possess at any one time P, 4

under this beense

! A. Plutonium (Principal) . ,

,A. Sealed Source (s) A. 150 grams total, no >,

L 4 radionuclide Pu-238). -(Alcatel-Gipsie) single source to >;

i " exceed 1 gram Pu-238 h

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4 9. Authorized Use p

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N 4 'A . Recovery, analysis and storage of explanted nucicar pacemakers. W 6 q .

e H 4 CONDIT10h5 F

e 4 s . f s i Licensematerialmay'beusedatthe(l'icensee'sRiceCreekFacility,7000 > i

10. A.

2 d W i Central Avenue N.E., Minneapolis, Minnesota, ,;

p o 1 F E N B. The licensee is authorized to store one (1) Medtronic Model 9000 isotopic N

.$' 4 pulse generator at each of the licensee's seven ' district offices in accordance >f V l with letters dated September 8, 1977, September 27, 1977, June 26, 1985 and [

August 8, 1991. Storage at district offices shall not exceed 30 days, j,1 d p 1 >

?n4 11. License material shall be used by, or under the supervision of, individuals designated by the licensee's Radiation Safety Committee, Thomas Hawkinson, Chairman.

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12. The Radiation Protection Officer for the activities authorized by this license is Thomas Hawkinson, j p

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Ilh I["I U. S. t E AR REGULATORY COMMIS$lON W pg 2 y 3 ,, ) l Mi. !A- LKen,e number p; q SNM-1156 p ;{

' MATERIALS t.ICENSE ) i SUPPLEMENTARY SHEET go, y, g,- )

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u. q Amendment No. 21 p

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% 4 The source (s) specified in Item (s) 7. A. shall be tested for leakane and/or >l contamination at intervals not to exceed 6 months. Any source received '

M, l Y frem another person which is not accompanied by a certificate indicating I' l that a test was performed within 6 months before the transfer shall not' li q '

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] g be put into use until tested.

4 p h ( (2) )

r 1 3 Notwithstandirig the periodic leak test required by this condition, any >

y licensed sealed source is exernpt from such leak tests when the source > I!

l y contains 100 microcuries or less of beta and/or gamma emitting material g

or 10 microcuries or less of alpha emitting material, f, :l ,

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'.  ! Anysourceir,storageand(r,useortransfersdb is removed fren stor ge\fo ot be tested. When the source j before use or transfc d ther person, it shall be testod >

p l C. The test shall bhapable of detecting the presence g

radioactive materla }co rt the test sarnple. If the. test 'ceVeals 0.005 microcurie of l q < the presence p il of 0.005 micrgc' G ie ord o e of removable contar2inat' ion,4hc source shall be )

renoved from 64/vice ind 6I b

4 with Comiss fon regulatic ontaminated,repj7f,ordisposedofinaccordance

\ repbr t',s hil c; filed wif.hin 5 days of the date >

l the leak test., result is@kr v i t h > t'h e,' U . 5. clear Regu kt q

Region 111, 799 Roosevelp,ydf The r[epor esti lldaATTN: Chief, lyr), gllin

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a Nuclear Matchiels Safe ydr a specif y

p untlts,J,orre.qMvg demi6t r inqhgtedp? Kecords q[yi.he leak testsource results involved

, i 4 the shalltest be resy#in kept >

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i s ma,o mdUba ll' beiAinta$ed for inspection >

by the Corrmisbnn. y r :1 N5ed of fdhwinfCbnmission inspection. >

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4 D. Tests for leakbeh and/o'r' c&& .a j1:ontaminAtio@ s@ hart t#

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t. g other persons spefjfically liceMed. by3he.tg;rp(o perform [d byythe issiorbranAgreenentStateto fI perform such serviggs,. 'LON ' '

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14. Scaled sources containing cens d material shall not b opened, k 15.- itedtronic, Inc. , sha ll collect, allkarksdbNit a report annually to the U.S.

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I 4 Nuclear Regulatory Comission, Region III, 799 Roosevelt Road. Glen Ellyn, Illineis 60137, ATTH: y 4

Chief, Nuclear Materials Safety and Safeguards Granch. The report h j

shall include data received from all investigators in accordance with the >

l procedures described in pages 2 and 3 of "Medtronic Laurens-Alcatel Model 9000 5 q lsotopic Pulse Generator CLINICAL INVESTIGATION PLAN" dated March 21, 1973. f

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d' p li The licensee may transport licensed naterial in accordance with the provisions of b4 10 CFR Part 71, " Packaging and Transportation of Radioactive Material." >

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17. Except for plutonium contained in a medical device designed for individual huNn application, no pluten tum, regardless of form, shall be delivered to a carrier for f' 1 (g g 45 d'

shipment by air transport or transported in an aircraft by the licensee except in p-packages the design of which the NRC has specifically approved for transport of 4 plutonium by air. >~

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-o , N -:7 Amendment No. 21 y I i -

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Mi 718 The licensee shall maintain records of information important to safe and effective > l

• ' 4 decommissioning at the address specified in License Item 2 per the provisions of >

bg, Iq ?} '10 CFR 70.25(g) until this license is terminated by the Concission. >

.){ l {Ml9., Except as specifically provided otherwise in this license, the licensee shall l Q

4 g conduct its program in accordance with the statements, representations, and >

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l  ;. procedures contained in the documents including any enclosures, listed below. )

, t . The fluclear Regulatory Commission's regulations shall govern unless the statements, h

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-representations and procedures in the licensee's application and correspondence are l<

q more restrictive than the regulations. l :

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' " '  ! A. Application dated August 6 an s pkb fi s dated f4ay 26, 1970,  ! l October 23, 1970, Ma 1 9 , August 18, 7 ., 1971, b g February 28, 1972, g'st29,1972, J March 5,197I}.eptember14, Jfarch 23, 1973, 8 u 4 [ May 10, 1973, Sep.tb er 5, 1974, llarch 24, 1975. A(r 4 8, 1976, October 7,1976,(t>bruary10, 1977, September 8, 197 d September 27, 1977; l l

and p*f , }. Cg N d.

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Letters Occember dated 5, JM1 4#ne.p.26,M,\(Renewal), llay ? )$jd6, Augud)t 8,1991 an R 4

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. - l Date; b/.}' 27, iY ?

By C n- :YA

Tiatorials Licensino Section, Reginn !!

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