ML20147G478

Corrected Amend 20 of License SNM-1156 for Medtronic Inc, Amending License in Entirety

ML20147G478
Person / Time
Site:	07001209
Issue date:	08/26/1987
From:	Mccann G NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:
Shared Package
ML20147G484	List: ML20147G478 ML20147G519
References
NUDOCS 8801220128
Download: ML20147G478 (3)

Text

(UKfXWWWCLMSROFA%MT(af?[Ma&MA%MZZnfiniM

! NRC Fum 374 W

MPAGE MIMi!1 GIT OF lG3li:'3h 3

PAGES

}d U.fs. NUCLS'AR REGULATORY COMMISSION I

CORRECTED COPY MATERIALS LICENSE Amendment No. 20 fh l Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93 -438), and Title 1 ll Code of Federal Regulations, Chapter I, Parts 30,31,32,3 3,34,35,40 and 70, and in reliance on statements and representat heretofore made by the licensee, a license is hereby issued auth,rizing the licensee to receive, acquire, possess, and transfer byproduct. .

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 acccrdance with the regulations of the applicable Part(s). This l license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is j i

subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any e ! conditions specified below.  ;

i -

In accordance with letter dated June 26, 1985

1. Medtronic, Inc. 3. License number SNM-1156 is amended in i

its entirety to read as follows:  !

~

~~

2. 7000 Central Avenue N.E. . ,_

! Minneapolis, MN 55432 , 4. Eipltation'date August 31, 1991 l 5. Docket or Reference 50.

070-01209 l 6. Byproduct, tource, and/or q 7. Chemical and/or physical 8. Maximum amount that licensee

! special nuclear material foim may possess at any one time  ;

under this license j A. Plutonium (Principal' A.'SealedSource(s)' A. 125 grams total, i radionuclide Pu-238)> ,(Alcatel-Gipsie)-

'no single source i G

/ ,

\'

Eto exceed 1 gram i i

, .Pu-236 l

@[s

9. Authorized Use '

1 2 <

J > '

1

! A. Recovery, analysis and storige 'of explanted nuclear pacemakers'.

~

I i

~

CONDITIONS  :

l

10. A. Licensed material,may be used at 'thilicensee's Ric'e ' Creek Facility, 7000  ;

Central Avenue, Minheapolis, Minnesota and at the< licensee's Research  ;

Facility, 1500 Northdale Boulevard, Minneapolis,* Minnesota.  ;

i B. The licr.nsee is authorized to' store one (1)'Medtronic Model 9000 isotopic pulse Y

( generator at each of the licensee's seven district offices in accoraance with j

, letters dated September 8, 1977, September 27, 1977 and June 26, 1985. Storage j at district offices shall not exceed 30 days.

11. Licensed material shall be used by, or under the supervision of, individuals M g designated by the licensee's Radiation Safety Committee, Thomas Hawkinson, Clairmar:. j 1

y 1 g

! 8801220128 870826 d l REG 3 LIC70 SNM-1156 PDR p

e Q, /

C0PY g y /

f4 h e e x s r M x r x 1 x s w r w s h e se x x e s s x v. h n r x r. w h e m e x

• C L V! a

p m a a p - mmm am a a a m m innmam m a mamm amm mmm mmmaaz mihm i-namm9 l NC0C Form 374A

,D U.S. NUCLEARJEGULATORY COMMISSION ( PAGE 2 OF 3 ,4ces i 4 License number l l MATERIALS LICENSE oocket or nererence num :

SUPPLEMENTARY SHEET 070-01209 l i P i Amendment No. 20 l l 12. A. (1) The source (s) specified in Item (s) 7. A. shall be tested for leakage and/or !

4 contamination at intervals not to exceed 6 months. Any source received i N from another person which is not accompanied by a certificate indicating h N that a test was performed within 6 months before the transfer shall not be >

l put into use until tested. l 4 y

'q (2) Notwithstanding the periodic leak test required by this condition, any y M licensed sealed source is exempt from such leak tests when the source n 4 contains 100 microcuries or less of beta and/or gamma emitting material >

or 10 microcuries or less of alpha emitting material.

l l l (3) Notwithstanding the other provision's 0fjthis leak test condition, lea %

2 l

4 tests are not required on: (1) pacemakers _ implanted in experimental y N animals provided that a leak test shall b'e performed immediately following i 4 removal of the' pacemakers from the animals, and-(2) on sealed sources >

contained in pacemakers that have been sterilized and packaged. l l

B. The test shall~be capable of detecting the presence of 0.005 microcurie of radioactive material on the test sample. If.the test reveC s the presence of g

4 0.005 microcurie or more.of removable contamination, the s' Jrce shall be removed b N from service.and decontaminated, repaired,~or' disposed ofon accordance with >

l Comission regulations. A; report shall bet filed within'5 days of the date the l g leak test result is known with the U.S. Nuclear Regulatory Commission, p

( Region 111,.799 Roosevelt Road, Glen:Ellyn, . Illinois 60137, ATTN: Chief, p Nuclear Materials Safety and Safeguards Branch.' The report shall specify the

~

4 N N source involved, the test results, and corrective action taken. Records of leak k j test results-shall be kept in units of' microcurie , and shall be maintained for Records may be disposed of following Conmission g

inspection by the Commission. g inspection.

f C.

Tests for leakage other persons and/or licensed specifically contamination shall be performed by the Commission by the licensee or an Agreement or by %p State to f

perform such services.

}I g 13. Sealed sources containing licensed material shall not be opened. )F k 5

% 14. Medtronic, Inc., shall collect, tally and submit a report annually to the U. S.  ;,

k Nuclear Regulatory Commission, Region III, 799 Roosevelt Road, Glen Ellyn, Illinois j; i 60137, ATTN: Chief, Nuclear Materials Safety and Sateguards Branch. The report ia

! shall include data received from all investigators in accordance with the procedures f

described in pages 2 and 3 ef "Medtronic Laurens-Alcatel Model 9000 Itatopic Pulse

j Generator CLINICAL INVESTIGATION PLAN" dated March 21, 1973. )j l 15. The licensee may transport licensed material in accordance with the provisions of g 10 CFR Part 71, "Packaging and Transportation of Radioactive Mater 41".

f

$j i

)

t i

i )y

.k l

! )

COPY >

~ httTJrdissT#mtT#mTMTNMTWJWrJWr.ws5tTXXJesUrWJWrXX.nTJrmr.TamsJra

.)

pm m msu m m mm mm mmm mm samm-Arammmmm m m m mmmmmmm Am m .maE m m9 l ,*NM84 C F or m 3 7 4 A U.S. NUCLEARf EGULI. TORY COMMISSION pace 3 og 3 , noes N l License number N SNM-1156 i i MATERIALS LICENSE " "'"#*""

SUPPLEMENTARY SHEET 070-01209 l i F i: CORRECTED COPY Amendment No. 20 y f 16. Except for plutonium contained in a medical device designed for individual human p I; application, no plutonium, regardless of form, shall be delivered to a carrier n

( for shipment by air transport or transported in an aircraft by the licensee >

! except in packages the design of which the NRC has specifically approved for f

[ transport of plutonium by air. l f 17. Except as specifically provided otherwise in this license, the licensee shall y i; conduct its program in accordance with the statements, representations, and y

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

! The Nuclear Regulatory Commission's regulations shall govern unless the statements, i

[ representations and procedures in the licensee's application and correspondence are E more restrictive than the regulations.

il (

k.

[ A. Application dated August 7,1969 and supplements dated May 26, 1970, ki i

October 26, 1970,-May 14, 1971, August 18, 1971, September 14, 1971, >:

February 28, 1972, Au gst 29, 1972, March 5, 1973, March 23, 1973, D' May 10, 1973, Septen er 5, 1974, March 24, 1975, April 8, 1976, October 7, 1976, February 10, 1977, September 8, 1977 and September 27, 1977; A(,

B. Applicationidate.! September 6,1979; and - _

);

F1 C. Letters dated 0:tober 12,.1979, Novembertil, 1980, March 18, 1982, June 26, F 1985 (Renewal) and May 21, 1986.

[

Pi I

lki bi a $>i I)F il k'

lli i n

O $

t g

i;  !>p i  !>

b

$j

[h m m

0 fi V For the U.S. Nuclear Regulatory Commission .

e i l >'

lii Original Signed

)>

I'

{ Date August 26, 1987 By George M. McCann 1 Materials Licensing Section, Region III i ><

1  :

! COPY

.TM%xM.T2r.rr&T&Tz3.wswxXvX%Tha&%TMTKTs#2:sLTJr##XT&Taaa.TMTaan