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Category:CORRESPONDENCE-LETTERS
MONTHYEARML20216F6081999-09-11011 September 1999
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
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Category:OUTGOING CORRESPONDENCE
MONTHYEARML20216F6081999-09-11011 September 1999
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
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Text
,G .
- W EYo UNITED STATES d~ ' NUCLEAR REGULATORY COMMisslON
~ 5'
[ j'%S REGION 111 RECEIVED t
f 799 ROOSEVELT RO AD GLEN ELLYN, ILLINOts 60137
{
MAY 0 51986 Medtronic, Inc. License Number: SNM-1156 ATTN: Charles H. Swanson, Ph.D. Expiration Date: Pending Renewal Director, Regulatory Affairs 7000 Central Avenue, Northeast Minneapolis, MN 55432 Gentlemen:
Ihis letter concerns your NRC Material License listed above. Correspondence sent to the address on your license has been returned to us unopened. We have found through telephone contacts or other sources that you can be reached at the above address.
From our discussion with Cheryl on May 9, 1986, we learned that you have relocated. Please be advised that you must notify us of changes in your mailing address and/or place of use for radioactive material. Therefore, you should request and obtain an amendment to your license for such a change.
Any amendment request should be accompanied by the appropriate fee specified in 10 CFR Part 170. If you should plan to discontinue activities involving radioactive material, you should:
- 1. Dispose of all material possessed under this license. Disposal must comply with the requirements of 10 CFR 20.301 and with requirements, if any, of your license.
- 2. Complete the enclosed Form NRC-314, " Certificate of Disposition of Ma te rial . " Describe what material was involved, when the material was used and when the material was disposed of or transferred.
- 3. Return the completed Form NRC-314 to this office, within thirty days of the date of this letter, so that we can close our files on this license.
If the activities conducted under your license were subject to the reporting j requirement of 10 CFR 20.407, 20.408, or 19.13, please submit any outstanding -
reports as described in those regulations.
Sincerely, J A EA Bruce S. Mallett, Ph.D., Chief Materials Licensing Section
Enclosures:
- 1. 10 CFR Parts 19, 20 and 170 '7 E C E 1 V C-
- 2. Form NRC-314 ,,,,,,,.:
[,3. , i cc:. ;
8704200077 860725 REGION III REG 3 LIC30 SNM-1156 PDR
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