ML20246K382
| ML20246K382 | |
| Person / Time | |
|---|---|
| Site: | 07001401 |
| Issue date: | 03/06/1989 |
| From: | Cain C NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML20246K387 | List: |
| References | |
| NUDOCS 8903210580 | |
| Download: ML20246K382 (2) | |
Text
-- _ _ - _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _
pmm-----------m---------mmmmm.. - mmmmmmmmm---_
] NRC Form 374 PA GE ] OF 2 PAGES g
j (5 847> U.S. NUCLEAR REGULATORY COMMISSION
( Amendment No. 04 1 MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, jl Code of Federal Regulations, Chapter 1, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations y s heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, i 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
- license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is
- subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any 3 conditions specified below.
u j Licensee In accordance with letter dated 1 May 26, 1988'
't. Veterans Administration Medical Center 3. License number SNM-1365 is amended in its b entirety to read as follows:
4
] '
- 2. 4500 South Lancaster Road Dallas, Texas 75216
- 4. Expiration date March 31, 1994 l]
i lI 5. Docket or 070-01401 j
- Reference No.
j 6. Byproduct, source, and/or 7. Chemical and/or physical 8. Maximum amount that licensee i special nuclear material form may possess at any one time f
j under this license j j A. Plutonium (Principal A. Sealed Source A. One source not to i jj radionuclides Pu-238) exceed j ll 210 milligrams U
y 9. Authorized use .
Ji l fl A. As a cerrponent of Medtronic Model 9000 nuclear-powered pacemaker for clinical ;
j ; evaluation purposes. This license authorizes possessien of the pacemaker for y purposes of explanation, recovery and disposal, but not for implantation.
U H CONDITIONS i t
l:l 10. Licensed materici shall be used only at Veterans Administration Medical Center, O 4500 South Lancaster Road, Dallas, Texas.
b ,f E
p 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 i p
[ use.
L 12, The licensee shall not receive or transfer in any single transaction, 1 gram or more of plutonium-238 contained in nuclear-powered pacemakers without notifying the i
[ Division of Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, !
c and, in addition, completing and distributing Form NRC-741 as required by Section 70.54 of 10 CFR Part 70.
l L 8903210580 890306 ,
i REG 4 LIC70 PNV I
SNM-1365 ,
--E
?
- l. , . . . . . . . . , ,, ,,.. , . . . . . . . <, , , , , , , . . . . . . . , . . , , , . . . . , , . , . , , , , . . . , . . , , , , , , , , , , , , , , , , , . , + . , , , , , , , , , , . , . , . , , , , , , ,g l Nxcpm 3MA ' U.S. NUCLEAR RE2ULATORY COMMISSION PAGE OF PAGES !
l 8084 , License number I p SNM-1365 1
- MATERIALS LICENSE oocket or nererence number I SUPPLEMENTARY SHEET 8 070-01401 5
Amendment No. 04 l l
E lq 13. The licensee shall report to the fledical, Academic, and Commercial Use Safety N
y q Branch, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> N q of occurrence, the death of any nuclear pacemaker patient, and any adverse reaction N N and/or malfunction involving a pacemaker system, including the leads. A written N I report giving details of the adverse reaction and/or malfunction shall be submitted l within 30 days.
l y
- 14. The licensee shall report to the liedical, Academic, and Commercial Use Safety W Branch, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, within 10 days, i I loss of contact with a. nuclear pacemaker patient.
l l 15. The licensee shall continue patient follow-up and replacement procedures for the l y nuclear pacemaker during the life of the patient; and procedures for recovery and p g authorized disposal of the nuclear pacemaker by return to the manufacturer shall be R i followed upon the death of the patient. >
N N lg 16. Except as specifically provided otherwise in this license, tfie licensee shall E conduct its program in accordance with the statements, representations, and a procedures contained in the documents, including any enclosures, listed below.
N The Nuclear Regulatory Commission's regulations shall govern unless the statements, representations, and procedures in the licensee's application and correspondence I are more restrictive than the regulations. j i A. Letter dated June 1, 1973 g
Letter dated liay 3,1974 l N B. .
$ C. Letter dated May 25, 1983
$ D. Letter dated May 26, 1988 ,
N N I N
N l l
4 j3 N l' l l
l l A f A B N
M p
4 - R 4 i k
- FOR THE U.S. NUCLEAR REGULATORY COMMISSION l>
lE t@,R 61939 Original signed by I
{
Ml Date -~
By n L. Cain I W Nucle- ials Licensing Section .f omcw.aecoac wy 't -
as 76011 #/ k
! 6 ) !
L L__ _ _ _ _ _ _ _ m m - m m , _ m - ~ 4'1 1
1 j
1