ML20153D070

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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:
References
SSD, NUDOCS 9809240298
Download: ML20153D070 (5)


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' O.S.' NUCLE AQ REGulA70RY COMMis$loN g

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 p

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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

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. 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

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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

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$- Q In accordance with letter dated 4

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Medtronic, Inc.

3. tjcense number SNM-ll56 is renewed in its k l entirety to read as follows:

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

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-Minneapolis, MN 5543?

4. Expiration date December 31, 1996 s (

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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,

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,A. Sealed Source (s)

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150 grams total, no A. Plutonium (Principal).

L 4 radionuclide Pu-238).

-(Alcatel-Gipsie) single source to i

exceed 1 gram Pu-238 h

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Authorized Use p

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'A Recovery, analysis and storage of explanted nucicar pacemakers.

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Licensematerialmay'beusedatthe(l'icensee'sRiceCreekFacility,7000 i

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i Central Avenue N.E., Minneapolis, Minnesota, p

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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

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August 8, 1991.

Storage at district offices shall not exceed 30 days, p

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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 j

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is Thomas Hawkinson, p

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U. S. t E AR REGULATORY COMMIS$lON W

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SUPPLEMENTARY SHEET go, y, g,-

070-01209

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q Amendment No. 21 p

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The source (s) specified in Item (s) 7. A. shall be tested for leakane and/or p 1

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contamination at intervals not to exceed 6 months. Any source received l

frem another person which is not accompanied by a certificate indicating I' l M,

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Notwithstandirig the periodic leak test required by this condition, any

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

g or 10 microcuries or less of alpha emitting material, Anysourceir,storageand(r,useortransfersdb nobb

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ng ot be tested. When the source is removed fren stor ge\\ o f

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The test shall bhapable of detecting the presence C.

0.005 microcurie of l

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If the. test 'ceVeals the presence o

of 0.005 micrgc' G ie ord o e of removable contar2inat' ion,4hc source shall be q

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6I ontaminated,repj7f,ordisposedofinaccordance b

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

the leak test., result is@kr Roosevelp,ydf The r[epor esti llda, Gjogf lyr), gllin l&

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clear Regu kt q

Region 111, 799 ATTN: Chief, a

Nuclear Matchiels Safe ydr y

,orre.qMvg qhgtedp? Kecords q[yi.he source involved a

specif i

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leak test results 4

shall be kept J

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Tests for leakbeh and/o'r' c&&

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other persons spefjfically liceMed. by3he.tg;rp(o perform [d by the t.

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Scaled sources containing cens d material shall not b opened, k

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itedtronic, Inc., sha ll collect, allkarksdbNit a report annually to the U.S.

Nuclear Regulatory Comission, Region III, 799 Roosevelt Road. Glen Ellyn, Illineis y

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60137, ATTH:

Chief, Nuclear Materials Safety and Safeguards Granch.

The report h

4 shall include data received from all investigators in accordance with the j

l procedures described in pages 2 and 3 of "Medtronic Laurens-Alcatel Model 9000 f

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lsotopic Pulse Generator CLINICAL INVESTIGATION PLAN" dated March 21, 1973.

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The licensee may transport licensed naterial in accordance with the provisions of li b 4 10 CFR Part 71, " Packaging and Transportation of Radioactive Material."

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Except for plutonium contained in a medical device designed for individual huNn f'

O1 (g application, no pluten tum, regardless of form, shall be delivered to a carrier for g

shipment by air transport or transported in an aircraft by the licensee except in p-45 d'

packages the design of which the NRC has specifically approved for transport of

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4 plutonium by air.

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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

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'10 CFR 70.25(g) until this license is terminated by the Concission.

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

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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 :'

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s pkb fi s dated f4ay 26, 1970, A.

Application dated August 6 an October 23, 1970, Ma 1

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1971, b

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February 28, 1972, J

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May 10, 1973, Sep.tb er 5, 1974, llarch 24, 1975. A(r 4 8, 1976, l

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