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Responds to FOIA request for documents re 3M Co license for I-125 seeds,implantable medical device.Forwards app documents.Documents & related records available in PDR.One record referred to FDA for disclosure determination.

Accession Number: ML20125A524

Date Released: Sunday, October 27, 2024

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• ML20128G434 - Responds to FOIA request for documents re 3M Co license for I-125 seeds,implantable medical device.Forwards app documents.Documents & related records available in PDR.One record referred to FDA for disclosure determination. (3 page(s), 11/2/1984)
• ML20128G603 - Responds to 800725 request for addl info re application for amend to License 22-00057-59MD,authorizing distribution of I-125 seeds.Package inserts for Models 6701,6702 & 6711 encl,per 800603 & 16 ltrs & 800709 telcon. (8 page(s), 11/26/1980)
• ML20126D820 - Submits addl info requested by NRC 800612 telcon re application to amend Matl/Byproduct License 22-0057-59MD. Package inserts for I-125 seeds will be revised. (2 page(s), 6/16/1980)
• ML20125A525 - Application for amend of Matl/Byproduct License 22-00057-59MD re distribution of I-125 seeds. (184 page(s), 3/15/1979)
• ML20126D899 - Confirms 800709 telcon re registered trademark.Phrase, "I-125 Seeds," considered registered trademark of vendor & will be denoted as such in licensing statements required by 10CFR32.74(a)(3) for Model 6701,6702 & 6711 products. (1 page(s), 7/25/1980)
• ML20128G611 - Application for amend to License 22-00057-59MD,authorizing distribution of I-125 seeds in carrier,Model 6720 based on encl info.W/o encl.Fee paid. (1 page(s), 5/1/1981)
• ML20126B073 - Application for amend to License 22-00057-59MD, authorizing distribution of I-125 seeds in Model 6711.Fee paid. (65 page(s), 2/8/1980)
• ML20128G645 - Forwards 830301 announcement of commercial availability of Model 6711 I-125 seeds,distributed under License 22-00057-59MD,in response to 830405 telcon. (2 page(s), 4/8/1983)
• ML20128G584 - Notifies that Model 6711 sealed source design acceptable for licensing purposes,based on 800208,0418,0508 & 0603 submittals.Certificates of registration for Models 6711,6701 & 6702 encl. (10 page(s), 6/27/1980)
• ML20125A988 - Ack receipt of Matl/Byproduct License 22-00057-59MD amended for distribution of I-125 seeds.Amend does not appear to provide max mCi required for Model 6701 seed.Requests assistance in verifying license condition or need to amend. (8 page(s), 8/3/1979)
• ML20128G449 - Responds to 790511 request for addl info re application for amend to License 22-00057-59MD,authorizing distribution of I-125 seeds.Color samples of labels & revised package insert encl. (10 page(s), 5/30/1979)
• ML20125A520 - Forwards application for amend of Matl/Byproduct License 22-00057-59MD.Fee paid. (2 page(s), 3/15/1979)
• ML20128G623 - Submits clarifying info re 810501 application for amend to License 22-00057-59MD,in response to 810626,30 & 0701 requests.Prototype tests for Model 6720 same as for Models 6701 & 6711.Supporting documentation encl. (20 page(s), 6/30/1981)