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Category:DKT 30 MTL BYPRODUCT
MONTHYEARML20210G1761999-05-18018 May 1999 Matls Licensing Package for Amend 25 to License SNM-1319 for Biocontrol Technology,Inc.Control:126847 ML20128G3691996-07-21021 July 1996 Matls Licensing Package for Amend 24 to License SNM-1319 for Biocontrol Technology,Inc.Control:119960 ML20058H8081993-10-19019 October 1993 Matls Licensing Package for Amend 23 to License SNM-1319 for Biocontrol Technology,Inc.Control:113332 ML20127C4141992-11-24024 November 1992 Thirty-Sixth Semi-Annual Rept for Period 920301-0831 ML20062A8161990-10-0303 October 1990 Discusses Telcon Inquiry 90-001 Re Activities Authorized by License SNM-1319.Renewal Application Received ML20155F5661987-10-31031 October 1987 Forwards Corrected Amend 21 to License SNM-1319.Amend Corrected,Per 870922 Request.Condition 13 Std for Stated Licenses.Memo Indicating That Not Amend But Corrected Copy W/Voiding Date of 871031 Encl ML20155F5391987-10-31031 October 1987 Corrected Amend 21 to License SNM-1319 for Biocontrol Technology,Inc,Amending License in Entirety ML20155F5941987-09-22022 September 1987 Requests Reissuance of Amend 21 to License SNM-1319 W/Stated Changes,Including Changing of Radiation Safety Officer from Fj Shipko to Jn Klingensmith & Indication That Ide No Longer in Effect ML20151D8601987-09-10010 September 1987 Forwards Amend 21 to License SNM-1319 ML20151D7901987-09-10010 September 1987 Amend 21 to License SNM-1319 for Biocontrol Technology,Inc, Amending License in Entirety ML20151D8841987-08-11011 August 1987 Forwards Amend 20 to License SNM-1319.Fee Paid ML20155F5991987-08-11011 August 1987 Application for Renewal of License SNM-1319,changing Company Name from Coratomic,Inc to Biocontrol Technology, Inc & Changing Radiation Safety Officer from Fj Shipko to Jn Klingensmith ML20151D9531987-08-0606 August 1987 Requests Fee Re 870715 Application for Amend to License SNM-1319.Fee Required Prior to Issuance of Amend ML20151D9261987-07-15015 July 1987 Application for Amend to License SNM-1319,changing Corporate Name to Biocontrol Technology,Inc ML20215F1611986-10-0303 October 1986 Ack Receipt of Informing NRC of Steps Taken to Correct Violations Noted in Insp 70-1342/86-01 ML20215F1731986-09-18018 September 1986 Responds to NRC Re Violations Noted in Insp 70-1342/86-01.Corrective Actions:Vendor Will No Longer Ship nuclear-powered Pacemakers Internationally Under UN2911, Until Type B Package Obtained ML20215B3121986-08-21021 August 1986 Forwards Amend 20 to License SNM-1319 ML20215B2921986-08-21021 August 1986 Amend 20 to License SNM-1319 for Coratomic,Inc,Amending License in Entirety ML20215B3661986-07-24024 July 1986 Requests Fee for 860710 Application for Amend to License SNM-1319 ML20215B4001986-07-16016 July 1986 Forwards Fee for 860710 Application for Amend to License SNM-1319 ML20215B3331986-07-10010 July 1986 Application for Amend to License SNM-1319,including 4.73-Ci Pu-238 Nuclear Source.Fee Paid ML20133P4361985-09-25025 September 1985 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 ML20133P4451985-09-25025 September 1985 Forwards Amend 19,renewing License SNM-1319 ML20133P4491985-09-16016 September 1985 Submits Suggested Wording for First Sentence of Condition 13 of Renewed License SNM-1319,requiring Collection of Data from Medical Institutions Re Accountability,Removal & Recovery of Model C-100,C-101 & C-101P Pacemakers ML20133P4521985-08-19019 August 1985 Responds to Request for Addl Info Re License SNM-1319.Model SAC-4 Scintillation Alpha Counter & Victoreen Model 488A Geiger Counter Will Be Used ML20133P4581985-08-0505 August 1985 Advises That Unless Response to 850529 Request for Addl Info Re 850502 Application for Renewal of License SNM-1319 Received within 30 Days,Application May Be Denied & License Terminated ML20133P4641985-05-29029 May 1985 Requests Addl Info Re 850502 Application for Renewal of License SNM-1319,including Info Re Survey Meters & Counting Equipment for Alpha & Neutrons & Outline of Annual Training Lecture Subjs ML20133P4681985-05-0202 May 1985 Forwards Application for Renewal of License SNM-1319 ML20133P4761985-05-0202 May 1985 Application for Renewal of License SNM-1319,authorizing Use of Pu-238 as Component of Coratomic Models C-100,C-101 & C-101P Pacemakers ML20133P4971985-03-0404 March 1985 Ack Receipt of Request for Complete Application for Renewal of License SNM-1319 ML20133P5131985-02-15015 February 1985 Requests Addl Info Re 840405 Application for Renewal of License SNM-1319,including Clarification of Reason for Not Sending Accountability Repts Since 830630,per License Condition 13.B ML20133P5281984-11-20020 November 1984 Forwards Human Implantation Protocol for Coratomic C-101-P Radioisotope Powered Cardiac Pacer. Protocol Approved by Nrc.Hosps Applying for Licenses to Implant Coratomic Model C-101-P Pacer Will Follow Protocol ML20133P5321984-10-0404 October 1984 Ack Receipt of Application for Renewal of License SNM-1319. License Will Not Expire Until Final NRC Action Taken ML20133P5431984-04-25025 April 1984 Forwards Fee for Application for Renewal of License SNM-1319 ML20133P5591984-04-20020 April 1984 Requests Fee for 840405 Application for Renewal of License SNM-1319.Fee Required Prior to Issuance of Amend ML20133P5621984-04-0505 April 1984 Application for Renewal of License SNM-1319,authorizing Transfer of Coratomic Model C-101 nuclear-powered Pacemakers to Medical Institutions Licensed by NRC or Agreement State ML20133P4881975-11-0101 November 1975 Human Clinical Protocol for Coratomic C-101 Radioisotope Powered Cardiac Pacer ML20133P4801975-07-0101 July 1975 Human Clinical Protocol for Coratomic C-100 Series Radioisotope Powered Cardiac Pacers 1999-05-18
[Table view] Category:LICENSE
MONTHYEARML20210G1761999-05-18018 May 1999 Matls Licensing Package for Amend 25 to License SNM-1319 for Biocontrol Technology,Inc.Control:126847 ML20128G3691996-07-21021 July 1996 Matls Licensing Package for Amend 24 to License SNM-1319 for Biocontrol Technology,Inc.Control:119960 ML20058H8081993-10-19019 October 1993 Matls Licensing Package for Amend 23 to License SNM-1319 for Biocontrol Technology,Inc.Control:113332 ML20155F5391987-10-31031 October 1987 Corrected Amend 21 to License SNM-1319 for Biocontrol Technology,Inc,Amending License in Entirety ML20151D7901987-09-10010 September 1987 Amend 21 to License SNM-1319 for Biocontrol Technology,Inc, Amending License in Entirety ML20215B2921986-08-21021 August 1986 Amend 20 to License SNM-1319 for Coratomic,Inc,Amending License in Entirety ML20133P4361985-09-25025 September 1985 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 1999-05-18
[Table view] Category:SNM & AMEND TO LICENSE (DKT 70S)
MONTHYEARML20210G1761999-05-18018 May 1999 Matls Licensing Package for Amend 25 to License SNM-1319 for Biocontrol Technology,Inc.Control:126847 ML20128G3691996-07-21021 July 1996 Matls Licensing Package for Amend 24 to License SNM-1319 for Biocontrol Technology,Inc.Control:119960 ML20058H8081993-10-19019 October 1993 Matls Licensing Package for Amend 23 to License SNM-1319 for Biocontrol Technology,Inc.Control:113332 ML20155F5391987-10-31031 October 1987 Corrected Amend 21 to License SNM-1319 for Biocontrol Technology,Inc,Amending License in Entirety ML20151D7901987-09-10010 September 1987 Amend 21 to License SNM-1319 for Biocontrol Technology,Inc, Amending License in Entirety ML20215B2921986-08-21021 August 1986 Amend 20 to License SNM-1319 for Coratomic,Inc,Amending License in Entirety ML20133P4361985-09-25025 September 1985 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 1999-05-18
[Table view] Category:TEXT-LICENSE APPLICATIONS & PERMITS
MONTHYEARML20210G1761999-05-18018 May 1999 Matls Licensing Package for Amend 25 to License SNM-1319 for Biocontrol Technology,Inc.Control:126847 ML20128G3691996-07-21021 July 1996 Matls Licensing Package for Amend 24 to License SNM-1319 for Biocontrol Technology,Inc.Control:119960 ML20058H8081993-10-19019 October 1993 Matls Licensing Package for Amend 23 to License SNM-1319 for Biocontrol Technology,Inc.Control:113332 ML20155F5391987-10-31031 October 1987 Corrected Amend 21 to License SNM-1319 for Biocontrol Technology,Inc,Amending License in Entirety ML20151D7901987-09-10010 September 1987 Amend 21 to License SNM-1319 for Biocontrol Technology,Inc, Amending License in Entirety ML20155F5991987-08-11011 August 1987 Application for Renewal of License SNM-1319,changing Company Name from Coratomic,Inc to Biocontrol Technology, Inc & Changing Radiation Safety Officer from Fj Shipko to Jn Klingensmith ML20151D9261987-07-15015 July 1987 Application for Amend to License SNM-1319,changing Corporate Name to Biocontrol Technology,Inc ML20215B2921986-08-21021 August 1986 Amend 20 to License SNM-1319 for Coratomic,Inc,Amending License in Entirety ML20215B3331986-07-10010 July 1986 Application for Amend to License SNM-1319,including 4.73-Ci Pu-238 Nuclear Source.Fee Paid ML20133P4361985-09-25025 September 1985 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 ML20133P4761985-05-0202 May 1985 Application for Renewal of License SNM-1319,authorizing Use of Pu-238 as Component of Coratomic Models C-100,C-101 & C-101P Pacemakers ML20133P5621984-04-0505 April 1984 Application for Renewal of License SNM-1319,authorizing Transfer of Coratomic Model C-101 nuclear-powered Pacemakers to Medical Institutions Licensed by NRC or Agreement State 1999-05-18
[Table view] |
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I PAGE 1 OF 3
, 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.
y '* #
1 ty p j Licensee k 4 In accordance with application dated F
)g 1.
May 2, 1985
- 3. License number f:
Coratomic, Inc. SNM-1319 is amended in its h 4
J , , , entirety to read as follows:
AM 1< s, i, j
- 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
- , ;) ,bs I d ,[ 7 ' u'nder this license N qg ,-- ~-
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
- 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.
+f y 8511010010 850925 W9 w i E!
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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>
l g
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
4
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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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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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j
- 19. Except as specifically provided otherwise by this lice 5se', the licensee shall possess ]
1.
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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