|
|---|
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
[Table view]
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
[Table view] |
Text
- - . . _ .. . - . - _ . . . _ - . - . - - --
t SEP 161998 Mr. Charles Swanson Medtronic, Inc.
7000 Central Avenue NE CBC T275 Minneapolis, MN 55432.
Dear Mr. Swanson:
Based on the information submitted in your letter dated July 21,1998, we have transferred registration certificate NR-450 D 101-U to inactive status. The registration number of the certificate has been changed to NR-8104-D-801-S.
l Please review the registration certificate (copy enclosed) in its entirety and notify us immediately l
if there are any errors or omissions.
If you have any questions, please contact me at (301) 415-7894 or Mr. Steven Baggett at (301)415-7273 Sincerely, i
Materials Safety Branch Division of Industrial and Medical Nuclear Safety i Office of Nuclear Material Safety '
and Safeguards
Enclosure:
As stated cc w/ encl: SKimberley, LFDCB Distribution: 9 99,-ry P' Y
/'N
, SSSS r/f SSD-98-63 NEO1 DOCUMENT NAME: P:\MEDTCC.WPD T3 receive a copy of this document, Indicate in the box: *C' = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N* = No copy OFFICE MSB C MSBf g C l NAME USBhachu 4W SLBaggdtt l DATE 09//p/98 09/IP /98 OFFICIAL RECORD COPY
! 9809240250 980916
! PDR RC
.