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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- b. ( (S 80 U.S. NUCLEAR REGULATORY COMMISSION l
a h.I ' MAT'ERIALS LICENSE Amendment No. 03 l 4-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; ' l y 3 heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, g; y source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to ( N 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 subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any N conditions spec;fied below. ) In accordance with le'tter dated i j April 17, 1986 E l L a Blodgett Memorial Medical Center
- 3. Ucense number SNM-1614 is amended in j
its entirety to read as follows: g f i n m, i a 2. 1840 Wealthy Street, S.E. , i,EMiriti6n date p, N @, (p" j Grand Rapids, MI 49506 r s February 28, 1993 i 4. V
- 5. Docket or "T h
Reference No. 070-02204 g i
- 6. Byproduct, source, and/or
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- 7. Chemical and/or physical V8. Maximum amount that licensee i
j d C.
- (may possess at any one time i
special nuclear material form -{q% f /m
- dader this license N
C/) I a.' Sealed Source V ( W T s / A. Plutonium (Principal ~gd b W M &l.0 gram (4 '%p Gottoexceed250 radionuclidePu-238')' ) T) 1 $@,,/ individual sources h /' eg .JhWd h% L -milligramseach) NA s , h, M,B.M]Q"lliR1 SiiOFces # (M ,3 hggy f /f $3 r7 B. Plutonium (PrincipalO I a B.s1.125 grams (5 M0n W {! C f $individualsources radionucludePu-238)Q. ey% d ]gA h. 9 Cg milligrams each) % not to exceed 225 Q) M 20 /gtgg' \\ \\\\ /~, nf a% f .4 g (
- 9. Authorized Use 4
gwy-of N (/. a A. As a component of CoratomiBModel C-101 nuclear-powered cardia'c pacemakers for g g clinical evaluation purposes. 9 u y 'T f b & ? p B. 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
N 11. The specified possession limit includes all licensed material possessed by the '[ licensee under this license whether in storage, implanted in patients or otherwise in use. 8903020060 8802.17 I I REG 3 LIC70 6_____.
pMurk mmm mmmmmmmmmmmmmmammmxp l NRC Form 87(A U.S. NUCLEAR REGULATGRY COMMISSION 2 2 paces l PAGE OF 1,* Ucense number I S 1614 l MATERIALS LICENSE l SUPPLEMENTARY SHEET l 070-02204 g i 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 l 1 .and, in addition, completing and distributing Form NRC-741 as required by Section l l l 70.54 of 10 CFR Part 70. 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 report giving details of the adverMse reaction-and/or malfunction shall be submitted within 30 days. gp M C G(jj l h l The licensee shall report (to'the Material LicensinhNction, U.S. Nuclear Regulatory l 14. l 8 Commission, 799 Roose.velt Road, Glen Ellyn, Illinois 60137 within 10 days, loss of b 3 I N contact with a nuclea'r2 pacemaker patient. V I l
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- 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 O l l be followed upon he death o e pat'ient f Except as specifically provQed ictherNise"irrth'isil'icense, th~e7 licensee shall l 16. ( 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, more restrictive thin,the r,egulsjibilsD}g)(p "%)s_applic representations and> proc' dufe'siin th kliheris'sh e g f[) f 4 y b (jj/ g3 g 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 1 B, i' E a i R $4 N e. 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 Materials Licensing Section, Region III i LTNNETaaTALTamEEwhTNEWATmLLT*Tamamemamammar w@@ W_.___-________
h o# 'o UNITED STATES .( e l'" NUCLEAR F(EGULATORY COMMISSION 32/00 l ~,, n. I -3 ,E REGION 111. 799 ROOSEVELT RO AD (( o, %,..... j[ GLt.N ELLYN, ILLINOIS 60137 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: /d 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-V&} $h Data B. LICENSE FEE MANAGEMENT BRANCll I { l l 1. Fee Category and Amount: U 76 //d M 1/ ~ f/ I/2f ' 0 W 2. Correct Fee Paid. Application may be processed for: Amendment / Renewal License 3 Signed j,,, 4/P//W vate 1 ,..u __}}