ML20133P436

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Amend 19 to License SNM-1319 for Coratomic,Inc,Amending License in Entirety.License Authorizes Use of Pu-238 as Component in Assembled Coratomic Model C-101 Pacemakers
ML20133P436
Person / Time
Site: 07001342
Issue date: 09/25/1985
From: Johansen J
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
Shared Package
ML20133P439 List:
References
NUDOCS 8511010010
Download: ML20133P436 (3)
v • d • e


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, g (5 84) , U.S. NUCLEAR REGULATORY COMMISSION MATERIALS LICENSE Amendment No. 19 lI Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, g Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations p 3' heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, p: ,

q source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to 5: 4 1 :1 deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This E 3 license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is E ,

f subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effec g conditions specified below.

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1 ty p j Licensee k 4 In accordance with application dated F

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May 2, 1985

3. License number f:

Coratomic, Inc. SNM-1319 is amended in its h 4

J , , , entirety to read as follows:

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M P.O. Box 434 Indiana, Pennsylvania 15701 (CN' 4. S iration P date _ September 30, 1990 3 l
q .V' 5. Docket or f N g G Reference No. .070,-01342 g j!! 6. Byproduct, source,and/or A 7. Chemical and/or physical L8. Maximum amount that licensee il special nuclear material
  • Tmay possess at any one time N di form -o
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Jl A. Plutonium (Principal " A!' Sealed sources / .@n A. NotTto exceed 250 mill,igrams of Pu-238 per is radionuclidePu-238)] _(Pjutonium.bstteries)]l, a Q si/ c ( @ sealed source; 290 grams total pj 1l

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9. Authorized use en~~ u  ?!<aL q k f

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(1) For use as a component in assembled'Coratomic'Model C-101 pacemakers and as a

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A component in ithe assembly (manufacturing) of Coratomic:Model C-101-P pacemakers; p j for distribu ion to medical institutio'ns' authorized to receive pacemakers d

, pursuant to he terms .and conditions ~'of a specific ljcense issued by the Nuclear E Regulatory C mmission'o'r an Agreement State. y> d f, -t .

J ., !i h (2) For recover as a component of explanted Coratomic Model C-100, C-101 and C-101-P p pacemakers transferred from specific' lice'nsees, q 5 (3) For storage or disassembly and re-furbishing of the battery source from Coratomic Model C-100, C-101 and C-101-P pacemakers.

q CONDITIONS ie a !i
  1. 10. Licensed material shall be used only at the licensee's facilities, 300 Indian Spring l, 3 Road, Indiana, Pennsylvania. t M l" l11. The licensee shall comply with the provisions of Title 10, Chapter 1, Code of Federal i' ,

g Regulations, Part 19, " Notices, Instructions, and Reports to Workers; Inspections" j g and Part 20, " Standards for Protection Against Radiation."  !,

s I 1 12. Licensed material shall be used by, or under the supervision of, individuals who have "

I completed the training program as outlined in the letter dated August 19, 1985 and

have been designated by Frederick J. Shipko, Radiation Safety Officer.

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MATERIALS LICENSE SUPPLEMENTARY SHEET SNM-1319

' * * " '"'*""" ' ly R 070-01342 p M M Amendment No. 19 l

(continued) CONDITIONS q 13. As six month intervals Coratomic, Inc. shall collect and tally data from all medical y N institutions with respect to: (a) accountability, removal and recovery, (b) duration q H

8 of satisfactory if(performance of malfunction appropriate) of orall theimplanted time of service Coratomicbefore malfunction, Model and (c)

C-100, C-101, andnature M>

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C-101P nuclear-powered pacemakers. Within ninety (90) days of the six month period ending February 28 or August 31, one copy of the report shall be sent to the U.S. f p

g Nuclear Regulatory Commission, Division of Fuel Cycle and Material Safety, Material p" 4 Licensing Branch, Washington, D.C. 20555. A second copy of the report shall be sent to the U.S. Nuclear Regulatory Commission',7 R'e~gion.I Nuclear Materials Safety Section, a%l631 Park Avenue, King of Prussia;,; Pennsylvania -19,40.6.

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14. Coratomic, Inc., shall maintain records of the medical on,stitutions approved by the FDA for participation in IDE G 810104/A2 and the date of'FDA's approval of each l institution.

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15. This license does not' authorize-the implantation of pacemakers-into humans or animals.

i 16. A.

' .Q _ / llW n Each plutonium source shall.'be tested-for leakage at intervals not to exceed six (6) months. In the absence oT'a ce'rtificate' from a transfe'r indicating that a test has been made within six'(6)._m_onths,prio i to the transfer, a sealed source l received from another person.shall not be put~into use until tested. e 1

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B. The test shall be capable of detecting the prese,nce;o,f 0.005 microcurie of alpha contamination on the test sample.!jThe test sample'shall be taken from the source or from appropriate accessible surfac'e's of;the de'vice in which the sealed source p

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is permanently or semipermanently niounted o'~~ r stored. Records of leak test

, resultsshallbekeptinunitsofmicrocuries)andmaint'ainedforinspectionby l the Commission. ba- ~

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C. If the test reveals the presence of 0.005 microcurie or more of removable alpha j contamination, the licensee shall,immediately' withdraw the sealed source from use v

! and shall cause it to be decontaminat'ed and repaired by a person appropriately

licensed to make such repairs or to be disposed of in accordance with the

'l Commission regulations. Within five (5) days after determining that any source has leaked, the licensee shall file a report in duplicate with the U. S. Nuclear  ;

Regulatory Commission, Region I, Nuclear Materials Safety Section, 631 Park  ;

Avenue, King of Prussia, Pennsylvania 19406, describing the source, the test l l results, the extent of contamination, the apparent or suspected cause of source j

failure, and the corrective action taken.

D. The periodic leak test required by this condition does not apply to sealed l 8 sources that are stored and not being used. The sources excepted from this test j k shall be tested for leakage prior to any use or transfer to another person unless d

! they have been leak tested within six (6) months prior to the date of use or transfer.

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l MATERIALS LICENSE SNM-1319_ _ _ __

ll SUPPLEMENTARY SHEET  ! i 1 070-01342__ 1  !

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Amendrrie n t_No ._19_ jN l

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CONDITIONS

[(continued)  !

I Q q . 17. The licensee may transport licensed material or deliver licensed material to a g, H. carrier for transport in accordance with the provisions of Title 10, Code of Federal y R Regulations, Part 71, " Packaging of Radioactive Material for Transport and l11 4; Transportation of Radioactive Material Under Certain Conditions." i ll I 1E:

h,18. The licensee shall conduct a physical inventory every six (6) months to account for I all sealed sources received and possessed under the license. The records of the f

!1 E- inventories shall be maintained for two (2) years from the date of the inventory for  ! !

1. inspection by the Commission, and shall includec the quantities and kinds of licensed l )

material, location of sealed .so~urces 'a'nd the date off the inventory. j

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19. Except as specifically provided otherwise by this lice 5se', the licensee shall possess ]

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and bse licensed material described in Items 6, 7, and 8 of this license in accordance . '

1; withstatements,repre'sentations,andprocedurescontainedjnapplicationdatedMay2,l 8

'4i 1985 and letter dated August 19, 1985. TheNuclearRegulatodCommission's regulations shail go'vern the licensee's statements in applications or letters, unless j

]l l E. the statements are'more restrictive than the regulations, j 1

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Igl l' Ijl fl' For the U.S. Nuclear Regulatory Connission f onginal signed m i SEP 2 51985 Jenny M. Johansen l),y glDate By E. Nuclear Materials Safety and i E Safeguards Branch, Region I i King of Prussia, Pennsylvania 19406

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