ML20214V375
| ML20214V375 | |
| Person / Time | |
|---|---|
| Site: | 07001209 |
| Issue date: | 09/06/1979 |
| From: | Swanson C MEDTRONIC, INC. |
| To: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20197E336 | List:
|
| References | |
| 14045, NUDOCS 8610020262 | |
| Download: ML20214V375 (5) | |
Text
, _ _ - - -
p/Inc 70-1207-Medtrq 3055 O!Nighway Eght P.O. Box 1453 i
5Fk' M,nneapolis. Minnesota 55440
.(J 92% /['e'd[10DIC Tetephone 612 /574-4000 mm cae Meacnic recei 2 n s9a September 6, 1979
'm SEF 10 PM i l t Director of Nuclear Materials and Safeguards License Management Branch S W
- REf..
US Nuclear Regulatory Ccpghkyjhgg Washington D.C.
20555 Gentlemen:
The purpose of this letter is to apply for renewal of License SNM-ll56 initially granted September 30, 1969 and renewed September 30, 1974.
This license expires September 30, 1979.
Information for license renewal as specified in Title 10 CFR 570.21, S70.22 and S70.33 is -provided below or incorporated by references to the license and amendments.
1)
Applicant
- Medtronic, Inc.
3055 Old Highway Eight
' C P.O. Box 1453 fy Minneapolis,' Minnesota 55440 Medtronic, Inc. is incorporated in the State of Minnesota with Corporate Headquarters at the address listed above.
Principal Officers of the Corporation and their residential addresses are as tollows:
l l
Bert J. Amdahl Earl E. Bakken l
1930 Major Drive 2220 Midland Grove Road j
Minneapolis, MN 55422 Roseville, MN 55112 l
l-Charles F.
Cuddihy, Jr.
Richard L. Fast 16993 Chiltern Hills Drive 5656 Woodcrest Drive Minnetonka, MN 55343 Edina, MN 55424 George M.
Heenan John A. Meslow 16816 Grays Bay Blvd.
6 Hingham Circle l
Wayzata, MN 55391 Mendota Heights, MN 55118 Dale R. Olseth Gerard C. Planchon 132 Homedale Road 6 Rue Danton Hopkins, MN 55343 75006 Paris, France l n')
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l 8610020262 860811 MM5 '
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Charles D.
Ray, M.D.
Donald R.
Stone 2020 Willow Drive 1721 Canyon Lane, N.W.
Long Lake, MN 55356 New Brighton, MN 55112 Gerald D. Van Eeckhout 9 Ironwood Lane North Oaks, MN 55110 With the exception of Mr. Gerard Planchon who is a citizen of France, all principal officers are US
. citizens.
No control or controlling stock ownership is exercised over Medtronic, Inc. by any alien, foreign corporation or foreign government.
2)
Activity for Which the Special Nuclear Material is Requested Sealed plutonium sources are used as a power source for a cardiac pacemaker, specifically the Medtronic Model:
9000.
Medtronic, Inc. no longer manufacturers nuclear powered cardiac pacemakers.
License renewal is request-ed for the possession of sealed plutonium sources where the primary activity is associated with the receiving, analyzing and storing of explanted pacemakers.
No
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tests or other activities will be performed that will
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in any way compromise the containment of the encapsu-
. lated plutonium source.
As described in our license (SNM-ll56 ) and amendments, analysis and storage of sealed nuclear sources and nuclear powered cardiac pacemakers will occur at the following~ locations:
Rice Creek Facility 6970 Old Central Avenue Minneapolis, MN 55432 St. Anthony Facility 3055 Old Highway Eight Minneapolis, MN 55418 Research Facility 1500 Northdale Boulevard Minneapolis, MN 55433 Also, as described in our license and amendments we are allowed to store one Medtronice Model 9000 pacemaker at
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each-of seven of our district offices-.
This was'done to minimize delays and uncertainties inishipping these-pacemakers to physicians and their patients.
Medtronic wishes to retain storage capability at the district offices listed-below to provide a way-station, if necessary, in the return of explanted nuclear pace--
makers to Medtronic's facilities in Minneapolis.
The district offices are:
Medtronic, Inc.
59 Wharf Street Salem, MA 01970 Medtronic,-Inc.
2 Neshaminy Interplex, Suite 204 Trevose, PA 19047.
Medtronic, Inc.
1601 North Kent, Suite 916 Arlington,~VA 22209 Medtronic, Inc.
24800 Northwestern Highway, Suite 208 Southfield, MI 48075
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Medtronic, Inc.
23811 Chagrin Boulevard, Suite 335 Beachwood, OH 44122 Medtronic, Inc.
188 Industrial Road, Suite 118 Elmhurst, IL 60126 Medtronic, Inc.
111 Westport Plaza, Suite 815 St. Louis ~, MO 63141 3)
Time Period of License License renewal is requested for a period of five (5) years through Semptember 30, 1984.
4)
Name, Amount and Specifications of Nuclear Material The plutonium sources (Alcatel-GIPSIE) contain Pud 48 as the principle isotope.
Possession limit under license SNM-1156 is 125 grams total with no more than 1 gram Pu238 per source.
It is requested that'this limit be continued.
Detailed information with respect to the chemical and O
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physical form of plutonium so. ces has been supplied previously under licenae SNM-1276 (Docket No. 70-1209).
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5)
Qualification of Applicant Medtronic has had ten-years of experience in the design, manufacture and testing of implantable nuclear power 2d cardiac pacemakers.
Effective with the renewal of the License, Mr. Peter Roy will become the Radiation Safety Officer for Medtronic, Inc.
His qualifications are listed in Attachment 1.
Mr.
Bob Griffin, Director of Product Development, is the Project Manager for the Model 9000 Program.
Members of
- the Radiation Safety Committee are as follows:
Chairman of the Radiation Safety Committee and. Radiation Safety Officer, Peter Roy; Project Manager, Bob Griffin; Regulatory Affairs, Charles Swanson, Ph.D.;
Corporate Security and Safety Manager,. Bill Irwin; Manager of Health Services, Eva Barnard, R.N.; and Donald E. Barber, Ph.D.
(Certified Health Physicist, Professor of Hygiene and Director _ of Graduate Studies in Environmental Health
' at the University of Minnesota).
All Medtronic personnel responsible for the handling and testing of sealed nuclear sources and nuclear powered pacemakers have been instructed in proper handling and storage procedures as required by our License (SNM-ll56).
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6)
Equipment and Facilities Facilities in which sources are held and equipment used in monitoring and measuring are described in license SNM-1156 and amendments.
7)
Procedures to Protect Health and Minimize Danger Security precautions and monitoring procedures to protect health and minimize danger to life or property are de-scribed in license SNM-ll56 and amendments.
Communications with respect to this application for license renewal should be directed to Charles H.
Swanson, Ph.D.'at the telephone number listed below.
Sincerely, MEDTRONIC, INC.
MN Charles H.
Swanson, Ph.D.
Director, US Regulatory Affairs (612) 574-3409
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^ TACHMENT 1 1
%.e Qualifications of Proposed RADIATION SAFETY OFFICER Peter Alan Roy EDUCATION BS Biology, Southeastern Massachusetts University MPH candiate (pending plan B papers) University of Minnesota EXPERIENCE Academic Training U.S.
Naval Damage Control Officers Course, NTC, Treasure Island, CA; 12 weeks fire fighting, damage control, and nuclear, biological and chemical warfare counter measures.
University of Minnesota - Measurement and Application of Ionizing Radiation (basic radiation protection).
Jan. 78 - Present
- Senior Industrial Hygienist, Medtronic, Minneapolis, MN
- 1 June 77 - Dec. 77
- Industrial Hygienist, Industrial Health Engineering Assoc., Hopkins, MN; Industrial Hygiene counsulting Sept. 76 - Dec. 76
- Graduate Student, Industrial Hygiene School of Public Health, University of MN; NIOSH Fellowship June 75 - Sept. 76
- Research Assistant and Summer Employee, U.S.
EPA National Marine Water Quality Laboratory, Nanagansett, RI Sept. 73 - June 76
- Graduate Student, Biology Department, Southeastern Massachusetts University, No.
Dartmouth, MA; Laboratory experience with radionuclides used in chemical and biological research Sept. 70 - Aug. 73
- U.S.
Naval Officer, Jan.-Aug. 71, Damage Control Assistant, USS Sphinx (ARL-24);
Sept.-Dec. 71, NTC - Key West, FL; Jan. 72-Aug. 73 Watch / Communications Officer, U.S.
NAVDAC, Eleuthera, Bahama PROFESSIONAL MEMBERSHIPS
.n American Industrial Hygiene Association - Certified in Training, September 1979 Laser Society of America s.~ c. c ~
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