ML20147G519
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| ML20147G519 | |
| Person / Time | |
|---|---|
| Site: | 07001209 |
| Issue date: | 08/31/1987 |
| From: | Mccann G NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Swanson C MEDTRONIC, INC. |
| Shared Package | |
| ML20147G484 | List: |
| References | |
| NUDOCS 8801220135 | |
| Download: ML20147G519 (1) | |
Similar Documents at 07001209 | |
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Category:CORRESPONDENCE-LETTERS
MONTHYEARML20216F6081999-09-11011 September 1999
[Table view]Discusses Insp on 990811 with Continued in Ofc Review Through 990830.No Violations Noted.Concerns Noted Re Number of Nuclear Powered Cardiac Pacemaker Devices Not Returned as of Annual Rept Submitted by ML20198B3961998-11-0101 November 1998 Forwards Summary of Clinical Evaluation Study of Medtronic Implantable Demand Isotopic Pulse GENERATOR,Laurens-Alcatel Model 9000.Closing Date for Data in Rept Is 981001 ML20153C9371998-09-16016 September 1998 Informs That Based on Info Submitted in , Registration Certificate NR-450-D-101-U Has Been Transferred to Inactive Status.Registration Number of Certificate Has Been Changed to NR-8104-D-801-S ML20153C9931998-07-21021 July 1998 Forwards Answers to List of Items Needing Resolution Before License Would Be Considered Inactive, Per 980709 Telcon ML20199A8331997-11-0101 November 1997 Forwards Summary of Clinical Evaluation Study of Medtronic Implantable Demand Isotopic Pulse Generator, laurens-alcatel Model 9000.Rept Submitted as Update of Summary of Clinical Evaluation Study Submitted 971101 ML20134K8281996-11-0101 November 1996 Forwards Medtronic Implantable Demand Isotopic Pulse Generator Laurens-Alcatel Model 9000 Summary of Clinical Evaluation Study, Dtd Oct 1996 ML20153D0421993-03-10010 March 1993 Advises That T Hawkinson No Longer Employee of Medtronic, Inc & That C Swanson Will Temporarily Assume Duties of Chair of Radiation Safety Committee & RSO ML20147G5191987-08-31031 August 1987 Forwards Corrected Copy of Amend 20 to License SNM-1156 ML20214V2791986-08-11011 August 1986 Forwards Amend 20,renewing License SNM-1156.Attention Directed to Condition 10.B Which Authorizes Temporary Storage at District Ofcs for Period Not to Exceed 30 Days ML20215H1161986-05-0505 May 1986 Informs That Licensee Must Advise NRC of Changes to Mailing Address.Application for Amend to License SNM-1156 Reflecting Change of Address,Required ML20214V2941985-07-0909 July 1985 Ack Receipt of Application for Renewal of License SNM-1156 ML20197E3311979-10-12012 October 1979 Updates Application for Renewal of License SNM-1156 Re Change in Membership of Radiation Safety Committee ML20214V3821977-09-27027 September 1977 Informs That All Persons Handling Medtronic Model 9000 Are Medtronic Employees & Have Been Instructed in Handling & Storage of Device ML20214V4531973-05-10010 May 1973 Informs That Medtronic Agrees to Amend License SNM-1156 to Limit Model 9000 Isotopic Pulse Generators Transferred During Study Program ML20214V4591973-03-23023 March 1973 Forwards Medtronic Laurens-Alcatel Model 9000 Isotopic Pulse Generator,Clinical Investigation Plan ML20214V5861970-05-0404 May 1970 Submits Addl Info in Support of Application for Amend to License SNM-1156,per Medtronic,Inc Request.Qc Procedures Listed ML20214V6001970-02-13013 February 1970 Forwards Proprietary Drawings of Betacel Battery for Review in Connection W/Application for License.W/O Encl 1999-09-11 Category:DKT 30 MTL BYPRODUCT MONTHYEARML20198B3961998-11-0101 November 1998
[Table view]Forwards Summary of Clinical Evaluation Study of Medtronic Implantable Demand Isotopic Pulse GENERATOR,Laurens-Alcatel Model 9000.Closing Date for Data in Rept Is 981001 ML20199A8331997-11-0101 November 1997 Forwards Summary of Clinical Evaluation Study of Medtronic Implantable Demand Isotopic Pulse Generator, laurens-alcatel Model 9000.Rept Submitted as Update of Summary of Clinical Evaluation Study Submitted 971101 ML20134K8281996-11-0101 November 1996 Forwards Medtronic Implantable Demand Isotopic Pulse Generator Laurens-Alcatel Model 9000 Summary of Clinical Evaluation Study, Dtd Oct 1996 ML20057E4881993-07-16016 July 1993 Amend 22 to License SNM-1156,authorizing Use of Listed Licensed Matl ML20057A9461993-06-0808 June 1993 Considers Encl Application from Medtronic,Inc to Be Abandoned for Nonpayment of Fees ML20147G5191987-08-31031 August 1987 Forwards Corrected Copy of Amend 20 to License SNM-1156 ML20147G4781987-08-26026 August 1987 Corrected Amend 20 of License SNM-1156 for Medtronic Inc, Amending License in Entirety ML20214V2791986-08-11011 August 1986 Forwards Amend 20,renewing License SNM-1156.Attention Directed to Condition 10.B Which Authorizes Temporary Storage at District Ofcs for Period Not to Exceed 30 Days ML20214V2631986-08-11011 August 1986 Amend 20 to License SNM-1156 for Medtronic,Inc,Amending License in Entirety ML20133E2861985-07-19019 July 1985 Insp Findings & Licensee Ack on 850719 of License SNM-1156. Insp Findings:No Violations Observed.Steps Taken to Correct Violations Identified During Last Insp Verified ML20214V2941985-07-0909 July 1985 Ack Receipt of Application for Renewal of License SNM-1156 ML20214V3091985-06-26026 June 1985 Application for Renewal of License SNM-1156.Curriculum Vitae of TE Hawkinson Encl.Fee Paid ML20214V3131982-03-18018 March 1982 Application for Amend to License SNM-1156,adding T Hawkinson as Radiation Safety Officer.Resume of T Hawkinson Encl.Fee Paid ML20214V3251980-11-11011 November 1980 Application for Amend to License SNM-1156,authorizing B Griffin,G Vanderkelen,C Swanson & G Weber as Members of Radiation Safety Committee.Fee Paid ML20214V3751979-09-0606 September 1979 Application for Renewal of License SNM-1156,adding PA Roy as Radiation Safety Officer.Qualifications of PA Roy Encl ML20214V3821977-09-27027 September 1977 Informs That All Persons Handling Medtronic Model 9000 Are Medtronic Employees & Have Been Instructed in Handling & Storage of Device ML20214V3841977-09-0808 September 1977 Application for Amend to License SNM-1156,authorizing Storage of One Medtronic Laurens-Alcatel Model 9000 at Each of Seven District Ofcs ML20214V3991977-02-10010 February 1977 Application for Amend to License SNM-1156,reflecting Accurate Description of Conditions for Use of Sealed Sources of Plutonium & Increasing Possession Limit for Plutonium to 125 G ML20214V3391976-10-0707 October 1976 Application to Amend License SNM-1156,adding K Clow as Radiation Safety Officer.Qualifications of K Clow Encl ML20214V3501976-10-0707 October 1976 Application for Amend to License SNM-1156,incorporating Encl List of Corporate Officers ML20214V3581976-10-0707 October 1976 Application for Amend to License SNM-1156,increasing Number of Hosps Receiving Licenses to Implant Medtronic Model 9000 Pulse Generators to 300 ML20214V4341976-04-0808 April 1976 Application for Amend to License SNM-1156,increasing Possession Limit of Plutonium to 100 G,Deleting DW Douglas & Revising Condition 11 as Listed ML20214V4411975-03-24024 March 1975 Application for Amend to License SNM-1156,allowing Continuation of Clinical Investigation of Alcatel Model 9000 Isotopic Pulse Generator Until 760524 ML20214V4441974-09-0505 September 1974 Application for Renewal of License SNM-1156,revising Membership of Radiation Safety Committee ML20214V4531973-05-10010 May 1973 Informs That Medtronic Agrees to Amend License SNM-1156 to Limit Model 9000 Isotopic Pulse Generators Transferred During Study Program ML20214V4591973-03-23023 March 1973 Forwards Medtronic Laurens-Alcatel Model 9000 Isotopic Pulse Generator,Clinical Investigation Plan ML20214V4681973-03-21021 March 1973 Medtronic Laurens-Alcatel Model 9000 Isotopic Pulse Generator,Clinical Investigation Plan ML20214V4731973-03-0505 March 1973 Application for Amend to Licenses SNM-1156 & 22-13456-01, Authorizing Possession & Use of Radioactive Matls at Animal Research Facility in Minneapolis,Mn & Performance of NDT of radioisotope-fueled Implantable Cardiac Pacemakers ML20214V4831972-08-29029 August 1972 Application for Amend to License SNM-1156,authorizing Storage of Radioactive Matl at Location Designated on Encl Drawing.W/O Drawing ML20214V4951972-02-28028 February 1972 Application for Amend to License SNM-1156,adding Third Source Storage Area as Shown in Encl & Deleting E Cheatham & Adding Lr Bolduc as Chairman of Radiation Safety Committee. W/O Encl ML20214V5071971-09-14014 September 1971 Application for Amend to License SNM-1156,deleting Ref to Possession Limit for Gipsie Generators & Reflecting Listed Changes in Corporate Officers ML20214V5181971-08-18018 August 1971 Application for Amend to License SNM-1156,authorizing Transfer of Pu-238 Sealed Sources to Production Facility in Fridley,Mn ML20214V5291971-05-14014 May 1971 Application for Amend to License SNM-1156,authorizing Listed Changes to Radiation Safety Committee ML20214V5451970-10-23023 October 1970 Application for Amend to License SNM-1156,authorizing Use of SNM at Plant in Minneapolis,Mn & Possession & Use of 2.5 Ci Pu-238 in Thermoelectric Generators ML20214V5671970-05-26026 May 1970 Application for Amend to License SNM-1156,authorizing Possession & Use of SNM at Plant in Minneapolis,Mn & Increasing Max Surface Radiation Level of Pu-238 Generator from 100 to 500 Mrem/H ML20214V5861970-05-0404 May 1970 Submits Addl Info in Support of Application for Amend to License SNM-1156,per Medtronic,Inc Request.Qc Procedures Listed ML20214V6001970-02-13013 February 1970 Forwards Proprietary Drawings of Betacel Battery for Review in Connection W/Application for License.W/O Encl ML20214V6291969-08-0707 August 1969 Application for License to Handle Encapsulated Pu-238 at Plant in Minneapolis,Mn 1998-11-01 Category:OUTGOING CORRESPONDENCE MONTHYEARML20216F6081999-09-11011 September 1999
[Table view]Discusses Insp on 990811 with Continued in Ofc Review Through 990830.No Violations Noted.Concerns Noted Re Number of Nuclear Powered Cardiac Pacemaker Devices Not Returned as of Annual Rept Submitted by ML20153C9371998-09-16016 September 1998 Informs That Based on Info Submitted in , Registration Certificate NR-450-D-101-U Has Been Transferred to Inactive Status.Registration Number of Certificate Has Been Changed to NR-8104-D-801-S ML20147G5191987-08-31031 August 1987 Forwards Corrected Copy of Amend 20 to License SNM-1156 ML20214V2791986-08-11011 August 1986 Forwards Amend 20,renewing License SNM-1156.Attention Directed to Condition 10.B Which Authorizes Temporary Storage at District Ofcs for Period Not to Exceed 30 Days ML20215H1161986-05-0505 May 1986 Informs That Licensee Must Advise NRC of Changes to Mailing Address.Application for Amend to License SNM-1156 Reflecting Change of Address,Required ML20214V2941985-07-0909 July 1985 Ack Receipt of Application for Renewal of License SNM-1156 1999-09-11 |
Text
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O ,, O ms a w, Medtronic, Inc.
ATTN: Charles H. Swanson, Ph.D.
Director, Regulatory Affairs 7000 Central Avenue, N.E.
Minneapolis, MN 55432 Gentlemen:
P It has been brought to our attention that Amendment 20. to your NRC License No. SNM-1156 contained errors. We also direct your attention to Condition 15, which requires annual submission of the data specified in the license condition.
We apologize for any inconvenience. Should you he.ve questions concerning the license, please contact me at (312) 790-5625.
Sincerely, Original Signed By George M. McCann Materials Licensirg Section
Enclosure:
Corrected copy of Amendment No. 20 to NRC License No. SNM-1156 4
I t
Rill McCann/pd gggg2{gggg s7m 8/$k /87 SNM-1156 PDR J
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