ML20155F594
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| ML20155F594 | |
| Person / Time | |
|---|---|
| Site: | 07001342 |
| Issue date: | 09/22/1987 |
| From: | Klingensmith J BIOCONTROL TECHNOLOGY, INC. (FORMERLY CORATOMIC |
| To: | Jennifer Davis NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| Shared Package | |
| ML20155F542 | List: |
| References | |
| 107573, 107880, NUDOCS 8806160438 | |
| Download: ML20155F594 (1) | |
Similar Documents at 07001342 | |
|---|---|
Category:CORRESPONDENCE-LETTERS
MONTHYEARML20137B1321997-03-12012 March 1997
[Table view]Ack Receipt of Informing NRC of Steps Taken to Correct Violations Noted in Insp Rept 70-1342/96-01 ML20137B1521997-02-0707 February 1997 Responds to NRC 970107 NOV Re Violations Noted in Insp Rept 70-1342/96-01 on 961212.Corrective Actions:Physical Inventory Accounting for All Licensed Matl Was Completed on 970127 & Annual Rept for 1995/1996 Sent on 961226 ML20133E6351997-01-0707 January 1997 Discusses Insp 70-1342/96-01 on 961212 & Forwards Notice of Violation ML20248J4281992-11-20020 November 1992 Advises That Licensee Did Not Provide Valid Reason for Extension of Due Date of Invoice AMO2024-92,therefore Extension Cannot Be Granted ML20198E4541992-09-0303 September 1992 Requests Extension of 30-day Period Until Determination of Invoice Amount Can Be Made.Questions If Company Can Qualify for Small Entity Status ML20062A8161990-10-0303 October 1990 Discusses Telcon Inquiry 90-001 Re Activities Authorized by License SNM-1319.Renewal Application Received ML20155F5661987-10-31031 October 1987 Forwards Corrected Amend 21 to License SNM-1319.Amend Corrected,Per 870922 Request.Condition 13 Std for Stated Licenses.Memo Indicating That Not Amend But Corrected Copy W/Voiding Date of 871031 Encl ML20155F5941987-09-22022 September 1987 Requests Reissuance of Amend 21 to License SNM-1319 W/Stated Changes,Including Changing of Radiation Safety Officer from Fj Shipko to Jn Klingensmith & Indication That Ide No Longer in Effect ML20151D8601987-09-10010 September 1987 Forwards Amend 21 to License SNM-1319 ML20151D8841987-08-11011 August 1987 Forwards Amend 20 to License SNM-1319.Fee Paid ML20151D9531987-08-0606 August 1987 Requests Fee Re 870715 Application for Amend to License SNM-1319.Fee Required Prior to Issuance of Amend ML20215F1611986-10-0303 October 1986 Ack Receipt of Informing NRC of Steps Taken to Correct Violations Noted in Insp 70-1342/86-01 ML20215F1731986-09-18018 September 1986 Responds to NRC Re Violations Noted in Insp 70-1342/86-01.Corrective Actions:Vendor Will No Longer Ship nuclear-powered Pacemakers Internationally Under UN2911, Until Type B Package Obtained ML20206P3481986-08-21021 August 1986 Discusses Safety Insp 70-1342/86-01 on 860710 & Forwards Notice of Violation ML20215B3121986-08-21021 August 1986 Forwards Amend 20 to License SNM-1319 ML20215B3661986-07-24024 July 1986 Requests Fee for 860710 Application for Amend to License SNM-1319 ML20215B4001986-07-16016 July 1986 Forwards Fee for 860710 Application for Amend to License SNM-1319 ML20133P4451985-09-25025 September 1985 Forwards Amend 19,renewing License SNM-1319 ML20133P4521985-08-19019 August 1985 Responds to Request for Addl Info Re License SNM-1319.Model SAC-4 Scintillation Alpha Counter & Victoreen Model 488A Geiger Counter Will Be Used ML20133P4581985-08-0505 August 1985 Advises That Unless Response to 850529 Request for Addl Info Re 850502 Application for Renewal of License SNM-1319 Received within 30 Days,Application May Be Denied & License Terminated ML20133P4641985-05-29029 May 1985 Requests Addl Info Re 850502 Application for Renewal of License SNM-1319,including Info Re Survey Meters & Counting Equipment for Alpha & Neutrons & Outline of Annual Training Lecture Subjs ML20133P4681985-05-0202 May 1985 Forwards Application for Renewal of License SNM-1319 ML20133P4971985-03-0404 March 1985 Ack Receipt of Request for Complete Application for Renewal of License SNM-1319 ML20133P5131985-02-15015 February 1985 Requests Addl Info Re 840405 Application for Renewal of License SNM-1319,including Clarification of Reason for Not Sending Accountability Repts Since 830630,per License Condition 13.B ML20133P5281984-11-20020 November 1984 Forwards Human Implantation Protocol for Coratomic C-101-P Radioisotope Powered Cardiac Pacer. Protocol Approved by Nrc.Hosps Applying for Licenses to Implant Coratomic Model C-101-P Pacer Will Follow Protocol ML20133P5321984-10-0404 October 1984 Ack Receipt of Application for Renewal of License SNM-1319. License Will Not Expire Until Final NRC Action Taken ML20133P5431984-04-25025 April 1984 Forwards Fee for Application for Renewal of License SNM-1319 ML20133P5591984-04-20020 April 1984 Requests Fee for 840405 Application for Renewal of License SNM-1319.Fee Required Prior to Issuance of Amend 1997-03-12 Category:DKT 30 MTL BYPRODUCT MONTHYEARML20210G1761999-05-18018 May 1999
[Table view]Matls Licensing Package for Amend 25 to License SNM-1319 for Biocontrol Technology,Inc.Control:126847 ML20128G3691996-07-21021 July 1996 Matls Licensing Package for Amend 24 to License SNM-1319 for Biocontrol Technology,Inc.Control:119960 ML20058H8081993-10-19019 October 1993 Matls Licensing Package for Amend 23 to License SNM-1319 for Biocontrol Technology,Inc.Control:113332 ML20127C4141992-11-24024 November 1992 Thirty-Sixth Semi-Annual Rept for Period 920301-0831 ML20062A8161990-10-0303 October 1990 Discusses Telcon Inquiry 90-001 Re Activities Authorized by License SNM-1319.Renewal Application Received ML20155F5661987-10-31031 October 1987 Forwards Corrected Amend 21 to License SNM-1319.Amend Corrected,Per 870922 Request.Condition 13 Std for Stated Licenses.Memo Indicating That Not Amend But Corrected Copy W/Voiding Date of 871031 Encl ML20155F5391987-10-31031 October 1987 Corrected Amend 21 to License SNM-1319 for Biocontrol Technology,Inc,Amending License in Entirety ML20155F5941987-09-22022 September 1987 Requests Reissuance of Amend 21 to License SNM-1319 W/Stated Changes,Including Changing of Radiation Safety Officer from Fj Shipko to Jn Klingensmith & Indication That Ide No Longer in Effect ML20151D8601987-09-10010 September 1987 Forwards Amend 21 to License SNM-1319 ML20151D7901987-09-10010 September 1987 Amend 21 to License SNM-1319 for Biocontrol Technology,Inc, Amending License in Entirety ML20151D8841987-08-11011 August 1987 Forwards Amend 20 to License SNM-1319.Fee Paid ML20155F5991987-08-11011 August 1987 Application for Renewal of License SNM-1319,changing Company Name from Coratomic,Inc to Biocontrol Technology, Inc & Changing Radiation Safety Officer from Fj Shipko to Jn Klingensmith ML20151D9531987-08-0606 August 1987 Requests Fee Re 870715 Application for Amend to License SNM-1319.Fee Required Prior to Issuance of Amend ML20151D9261987-07-15015 July 1987 Application for Amend to License SNM-1319,changing Corporate Name to Biocontrol Technology,Inc ML20215F1611986-10-0303 October 1986 Ack Receipt of Informing NRC of Steps Taken to Correct Violations Noted in Insp 70-1342/86-01 ML20215F1731986-09-18018 September 1986 Responds to NRC Re Violations Noted in Insp 70-1342/86-01.Corrective Actions:Vendor Will No Longer Ship nuclear-powered Pacemakers Internationally Under UN2911, Until Type B Package Obtained ML20215B3121986-08-21021 August 1986 Forwards Amend 20 to License SNM-1319 ML20215B2921986-08-21021 August 1986 Amend 20 to License SNM-1319 for Coratomic,Inc,Amending License in Entirety ML20215B3661986-07-24024 July 1986 Requests Fee for 860710 Application for Amend to License SNM-1319 ML20215B4001986-07-16016 July 1986 Forwards Fee for 860710 Application for Amend to License SNM-1319 ML20215B3331986-07-10010 July 1986 Application for Amend to License SNM-1319,including 4.73-Ci Pu-238 Nuclear Source.Fee Paid ML20133P4361985-09-25025 September 1985 Amend 19 to License SNM-1319 for Coratomic,Inc,Amending License in Entirety.License Authorizes Use of Pu-238 as Component in Assembled Coratomic Model C-101 Pacemakers ML20133P4451985-09-25025 September 1985 Forwards Amend 19,renewing License SNM-1319 ML20133P4491985-09-16016 September 1985 Submits Suggested Wording for First Sentence of Condition 13 of Renewed License SNM-1319,requiring Collection of Data from Medical Institutions Re Accountability,Removal & Recovery of Model C-100,C-101 & C-101P Pacemakers ML20133P4521985-08-19019 August 1985 Responds to Request for Addl Info Re License SNM-1319.Model SAC-4 Scintillation Alpha Counter & Victoreen Model 488A Geiger Counter Will Be Used ML20133P4581985-08-0505 August 1985 Advises That Unless Response to 850529 Request for Addl Info Re 850502 Application for Renewal of License SNM-1319 Received within 30 Days,Application May Be Denied & License Terminated ML20133P4641985-05-29029 May 1985 Requests Addl Info Re 850502 Application for Renewal of License SNM-1319,including Info Re Survey Meters & Counting Equipment for Alpha & Neutrons & Outline of Annual Training Lecture Subjs ML20133P4681985-05-0202 May 1985 Forwards Application for Renewal of License SNM-1319 ML20133P4761985-05-0202 May 1985 Application for Renewal of License SNM-1319,authorizing Use of Pu-238 as Component of Coratomic Models C-100,C-101 & C-101P Pacemakers ML20133P4971985-03-0404 March 1985 Ack Receipt of Request for Complete Application for Renewal of License SNM-1319 ML20133P5131985-02-15015 February 1985 Requests Addl Info Re 840405 Application for Renewal of License SNM-1319,including Clarification of Reason for Not Sending Accountability Repts Since 830630,per License Condition 13.B ML20133P5281984-11-20020 November 1984 Forwards Human Implantation Protocol for Coratomic C-101-P Radioisotope Powered Cardiac Pacer. Protocol Approved by Nrc.Hosps Applying for Licenses to Implant Coratomic Model C-101-P Pacer Will Follow Protocol ML20133P5321984-10-0404 October 1984 Ack Receipt of Application for Renewal of License SNM-1319. License Will Not Expire Until Final NRC Action Taken ML20133P5431984-04-25025 April 1984 Forwards Fee for Application for Renewal of License SNM-1319 ML20133P5591984-04-20020 April 1984 Requests Fee for 840405 Application for Renewal of License SNM-1319.Fee Required Prior to Issuance of Amend ML20133P5621984-04-0505 April 1984 Application for Renewal of License SNM-1319,authorizing Transfer of Coratomic Model C-101 nuclear-powered Pacemakers to Medical Institutions Licensed by NRC or Agreement State ML20133P4881975-11-0101 November 1975 Human Clinical Protocol for Coratomic C-101 Radioisotope Powered Cardiac Pacer ML20133P4801975-07-0101 July 1975 Human Clinical Protocol for Coratomic C-100 Series Radioisotope Powered Cardiac Pacers 1999-05-18 Category:INCOMING CORRESPONDENCE MONTHYEARML20137B1521997-02-0707 February 1997
[Table view]Responds to NRC 970107 NOV Re Violations Noted in Insp Rept 70-1342/96-01 on 961212.Corrective Actions:Physical Inventory Accounting for All Licensed Matl Was Completed on 970127 & Annual Rept for 1995/1996 Sent on 961226 ML20198E4541992-09-0303 September 1992 Requests Extension of 30-day Period Until Determination of Invoice Amount Can Be Made.Questions If Company Can Qualify for Small Entity Status ML20155F5941987-09-22022 September 1987 Requests Reissuance of Amend 21 to License SNM-1319 W/Stated Changes,Including Changing of Radiation Safety Officer from Fj Shipko to Jn Klingensmith & Indication That Ide No Longer in Effect ML20151D8841987-08-11011 August 1987 Forwards Amend 20 to License SNM-1319.Fee Paid ML20215F1731986-09-18018 September 1986 Responds to NRC Re Violations Noted in Insp 70-1342/86-01.Corrective Actions:Vendor Will No Longer Ship nuclear-powered Pacemakers Internationally Under UN2911, Until Type B Package Obtained ML20215B4001986-07-16016 July 1986 Forwards Fee for 860710 Application for Amend to License SNM-1319 ML20133P4521985-08-19019 August 1985 Responds to Request for Addl Info Re License SNM-1319.Model SAC-4 Scintillation Alpha Counter & Victoreen Model 488A Geiger Counter Will Be Used ML20133P4681985-05-0202 May 1985 Forwards Application for Renewal of License SNM-1319 ML20133P4971985-03-0404 March 1985 Ack Receipt of Request for Complete Application for Renewal of License SNM-1319 ML20133P5281984-11-20020 November 1984 Forwards Human Implantation Protocol for Coratomic C-101-P Radioisotope Powered Cardiac Pacer. Protocol Approved by Nrc.Hosps Applying for Licenses to Implant Coratomic Model C-101-P Pacer Will Follow Protocol ML20133P5431984-04-25025 April 1984 Forwards Fee for Application for Renewal of License SNM-1319 1997-02-07 |
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