ML20235N985
| ML20235N985 | |
| Person / Time | |
|---|---|
| Site: | 07002204 |
| Issue date: | 02/17/1988 |
| From: | Vacherlon P NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20235N988 | List: |
| References | |
| 381143, NUDOCS 8903020060 | |
| Download: ML20235N985 (3) | |
Text
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' MAT'ERIALS LICENSE Amendment No. 03 l g i g 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 1, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations g; y '
l 3 heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, g; y N 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 accordance with the regulations of the applicable Part(s). This ( 5 N license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is E N N subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions spec;fied below.
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In accordance with le'tter dated i j L April 17, 1986 E < a Blodgett Memorial Medical Center 3. Ucense number SNM-1614 is amended in l j its entirety to read as follows: g ! f
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- 5. Docket or Reference No.
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- 6. Byproduct, source, and/or 7. Chemical and/or physical V8. Maximum amount that licensee
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A. Plutonium (Principal ~gd b W M &l.0 gram (4 radionuclidePu-238')' I a.') Sealed T) Source V
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milligrams each) l I g ( 9. Authorized Use (/ . 4 gwy- of a N g A. As a component of CoratomiBModel C-101 nuclear-powered cardia'c pacemakers for g clinical evaluation purposes. 9 u y p B.
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As a component of Cordis Nuclear Onini-Stanicor Model 184A nuclear-powered cardiac p pacemakers for clinical evaluation purposes, s
! This license authorizes possession of these pacemakers for purposes of explantation, ,
recovery and disposal, but not for implantation or reimplantation. {i ( n
; CONDITIONS y I i i 10. Licensed material shall be used only at the licensee's facilities located at Blodgett Memorial Medical Center, 1840 Wealthy Street, S.E., Grand Rapids, '
[ [ Michigan, f [
! 11. The specified possession limit includes all licensed material possessed by the N
'[ licensee under this license whether in storage, implanted in patients or otherwise in use.
!, 8903020060 8802.17
- I I REG 3 LIC70 !
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pMurk mmm ._ mmmmmmmmmmmmmmammmxp l NRC Form 87(A U.S. NUCLEAR REGULATGRY COMMISSION PAGE 2 OF 2 paces l 1 ,* , , Ucense number I
! '"- MATERIALS LICENSE '**"*
S 1614 l l SUPPLEMENTARY SHEET l i 070-02204 g i f 1 Amendment No. 03 ! l 12. The licensee shall not receive or transfer in any single transaction, 1 gram or more l l of plutonium-238 contained in nuclear-powered pacemakers without notifying the p I Division of Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, N 1 .and, in addition, completing and distributing Form NRC-741 as required by Section l 70.54 of 10 CFR Part 70. l l l , b l 13. The licensee shall report to the Material Licensing Section, U.S. Nuclear Regulatory y i Commission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 24 hours of p j i occurrence, the death of any nuclear pacemaker patient, and any adverse reaction > i
! and/or malfunction involving a pacemaker system, including the leads. A written !
' E l h report30 within giving days.details of the adverMseM gp reaction-and/or C G(jj malfunction shall be submitted l
- 14. The licensee shall report (to'the Material LicensinhNction, U.S. Nuclear Regulatory l l 8 Commission, 799 Roose.velt Road, Glen Ellyn, Illinois 60137 within 10 days, loss of b I N contact with a nuclea'r2 pacemaker patient. V 3 I
' I l % o *"h q 15. The licensee shallIchntinue atient follow-up and }ademiptiproceduresforthe !
nuclear pacemakerlduring thii l fe of the patierltd the procedures for recovery y andauthorizeddjsposalofth"e}fnu'c,leagpacemaksr{bfpeturnto~themanufacture N be followed upon he death o e pat'ient f l O l ! l 16. Except as specifically provQed ictherNise"irrth'isil'icense, th~e7 licensee shall ( conduct its prog ram inia'ccordsseMth,thediateinehtsfrkpresehtations, and I procedures contain6d iniths4documerits jihbiliding>Enyb' enclosures 7 listed below. i The Nuclear Regulatory Comniisslon s] egilliti$ns shal,ldovern~ijnless the statements, g representations and> proc' e dufe'siin th kliheris'sh 4 g more restrictive y thinb (jj/
,the r,egulsjibilsD}g)(p g3 f
f[) "%)s_applic 4 A. Letters dated Jan6ary 8, 1976, Ma "~14 1976 ' March-17, 1981 and April 17, 1986. P A/ k' f ,j ,. y 5 4 M
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I For the U.S. Nuclear Regulatory Commission ( g ( p , i F ' f P l Original Signed W
, Date: February 17, 1988 By Patricia M. Vacherlon _
i Materials Licensing Section, Region III < LTNNETaaTALTamEEwhTNEWATmLLT*Tamamemamammar w@@ W_.___-________ .---. --- . - . . - , - .
* * > h e o# 'o UNITED STATES .(
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l'" n . NUCLEAR F(EGULATORY COMMISSION 32/00 l
-3* ,E REGION 111.
I o, 799 ROOSEVELT RO AD (( GLt.N ELLYN, ILLINOIS 60137
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BETWECN: William O. Miller, Chief
' License Fee Management. Branch 1 Office of Administration ]
l Regional License Section 'I Material Licensing Branch FCMS, Office of Nuclear Material Safety & Safeguards
'I LICENSE FEE TRANSMITTAL- j A. REGIO
- 1. APPLICATION ATTACHED
, Applicant / Licensee: M /./X4/6F / d4 # Application Dated: ,
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control No.: CONTROL NO.3 811 4 3 License No.: dg,f/-/d/f
- 2. FEE ATTACllED 1
Amount: Check No.: [
- 3. COMP NTS Signed . d-Data V&} $h B. LICENSE FEE MANAGEMENT BRANCll I l l
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- 1. Fee Category and Amount: U 76 //d M -
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- 2. Correct Fee Paid. Application may be processed for:
1/ ~ f/ I/2f ' 0 Amendment / Renewal , License 3 Signed j,,, vate 4/P//W ,.. 1 u __}}