Category:CORRESPONDENCE-LETTERS
MONTHYEARML20211K3681986-05-0808 May 1986
Forwards Amend 4 to License SNM-1412
ML20211K3771983-07-13013 July 1983
Advises That License SNM-1412,authorizing Use of Pu-238 Nuclear Powered Pacemakers Will Expire on 830930.Procedures for Termination or Renewal of License Provided
ML20211K4031978-11-17017 November 1978
Advises That Medtronic 9000 Nuclear Pacemaker Retrieved from L Dresner & Returned to Hosp & Medtronic,Inc.Generator Returned Due to L Dresner Death on 781012
ML20211K4351974-03-14014 March 1974
Responds to Re License SNM-1412.Consents to Changes &/Or Mods to License as Outlined in Ltr
ML20211K4461974-02-21021 February 1974
Advises That License SNM-1412 Will Be Amended to Include Listed Conditions Re radioisotopic-powered Pacemaker Implants.Conditions May Be Added to License W/O Issuance of Formal Order If AEC Notified within 20 Days of Ltr Date
ML20211K4081973-12-28028 December 1973
Forwards Corrected License SNM-1412,changing Possession Limit for Nuclear Pulse Generator from 150 Mg to 210 Mg
ML20211K4411973-09-24024 September 1973
Forwards License SNM-1412,authorizing Use of Medtronic 9000 Pacemakers.Mfg May Not Be Able to Provide All Pacemakers Authorized in License Since Program Essentially Study Program
ML20211K3721973-08-31031 August 1973
Provides Necessary Info Requested for Application for Nuclear Pacemaker Insertions.Followup Experience of Five Cardiologists W/Regard to Total Number of Patients Provided
ML20211K4571973-08-23023 August 1973
Requests Listed Addl Info Re 730720 Application to Participate in Investigational Program Utilizing Medtronic Laurens-Alcatel Model 9000 Isotopic Pulse Generators.Info Required for Physician Responsible for Study
ML20211K3901973-07-20020 July 1973
Responds to Re Additions to Item 7 of License SNM-1412.Provides Names of Five Cardiologists Responsible for Followup Care of Pacemaker Patients That Should Be Included in Application
ML20211K4651973-07-10010 July 1973
Responds to Application for SNM License to Implant Medtronic Model 9000 Nuclear Powered Cardiac Pacemakers.Submittal of Info on pacemaker-related Training & Experience of Physicians & Surgeons Under Item 7 Required
1986-05-08
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Category:INCOMING CORRESPONDENCE
MONTHYEARML20211K4031978-11-17017 November 1978
Advises That Medtronic 9000 Nuclear Pacemaker Retrieved from L Dresner & Returned to Hosp & Medtronic,Inc.Generator Returned Due to L Dresner Death on 781012
ML20211K4351974-03-14014 March 1974
Responds to Re License SNM-1412.Consents to Changes &/Or Mods to License as Outlined in Ltr
ML20211K3721973-08-31031 August 1973
Provides Necessary Info Requested for Application for Nuclear Pacemaker Insertions.Followup Experience of Five Cardiologists W/Regard to Total Number of Patients Provided
ML20211K3901973-07-20020 July 1973
Responds to Re Additions to Item 7 of License SNM-1412.Provides Names of Five Cardiologists Responsible for Followup Care of Pacemaker Patients That Should Be Included in Application
1978-11-17
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