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Amend 9 to License SNM-1305 for Veterans Admin Medical Ctr, amending license in entirety.
Accession Number: ML20236P571
Date Released: Wednesday, October 23, 2024
Package Contents
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- ML20236P573 - Forwards Amend 9,renewing License SNM-1305. (2 page(s), 7/30/1987)
- ML20236P588 - Ack receipt of application for renewal of License SNM-1305. (1 page(s), 6/17/1987)
- ML20236P615 - Application for renewal of License SNM-1305 to combine current license w/License SNM-1305,continue followup of patients w/nuclear pacemakers & to retain AA Gage as physician responsible for nuclear pacermaker followup. (3 page(s), 4/30/1987)
- ML20236P635 - Application for renewal of License SNM-1305,authorizing possession & use of up to 30 Medtronic 9000 units & 60 Coratomic Model C-100 or C-101 units. (1 page(s), 6/2/1982)
- ML20237F854 - Submits addl info in support of application for renewal of License SNM-1305.Both Chardack & Gage participating in clinical evaluation of nuclear-powered cardiac pacemakers & JN Bhayana added to license as physician. (1 page(s), 7/25/1977)
- ML20237F857 - Forwards application for renewal of License SNM-1305. (1 page(s), 7/25/1977)
- ML20237F872 - Application for renewal of License SNM-1305,authorizing use of Medronic,Inc Model 9000 nuclear powered pacemakers. (2 page(s), 6/10/1977)
- ML20237F894 - Application for amend to License SNM-1305,authorizing use of Cordis nuclear pacemaker. (1 page(s), 3/10/1976)
- ML20237F899 - Application for amend to License SNM-1305,authorizing participation in research study involving implantation of Coratomic C-100 series nuclear powered pacemakers containing Pu-238. (1 page(s), 9/4/1975)
- ML20237F924 - Forwards application for amend to License SNM-1305. (1 page(s), 6/12/1975)
- ML20237F945 - Application for amend to License SNM-1305,authorizing participation in research study involving implantation of Coratomic C-100 nuclear powered pacemakers containing Pu-235. (1 page(s), 6/12/1975)
- ML20237G022 - Application for amend to License SNM-1305,authorizing 10 addl implantations of nuclear powered cardiac pacemakers in humans. (1 page(s), 2/28/1973)
- ML20237G031 - Submits first formal followup rept.Licensee operated on nine patients using Medtronic-Laurens-Alcatel Model 9000 nuclear powered cardiac pacemaker under License SNM-1305.Status rept & narrative summary on each patient encl. (9 page(s), 2/28/1973)
- ML20237G051 - Responds to 720502 telcon w/WM Chardack & 720504 requests for addl info on licensee application.Licensee to obtain permission by patient for removal of isotopic pulse generator in case of death. (4 page(s), 5/10/1972)
- ML20237G077 - Submits addl info in response to 710930 request re 710913 application for amend to License SNM-1305.Records of first seven patients of greater relevance since followup ranging from 6 months up to 2 yrs available. (9 page(s), 3/17/1972)