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Letter informing that Model TheraSphere therapeutic device is acceptable for licensing purposed in accordance wiht the conditions of the enclosed registration certificate (NR-0220-D-113-S).

Accession Number: ML003686322

Date Released: Friday, February 18, 2000

Package Contents

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• ML003686181 - Letter informing that Model TheraSphere therapeutic device is acceptable for licensing purposed in accordance wiht the conditions of the enclosed registration certificate (NR-0220-D-113-S). (1 page(s), 2/15/2000)
• ML003686183 - Letter returning the attachments as listed and accepting, as replacement, the drawing which had been attached to February 2, 2000 letter. (5 page(s), 2/14/2000)
• ML003686193 - Letter submitting further information regarding February 1, 2000 telephone conversation and January 19, 2000 letter pertaining to responses to comments for the device, TheraSphere. (5 page(s), 2/2/2000)
• ML003686201 - Letter responding to 991123 letter with comments pertaining to registration request for the device, TheraSphere. (24 page(s), 1/19/2000)
• ML003686206 - TheraSphere Label Integrity Report. (8 page(s), 2/23/1999)
• ML003686210 - Qualification Test Report of the F-400/F-390 Type 'A' Transport Package. (12 page(s), 1/12/1997)
• ML003686212 - Test Report for F390 Lead Pot and Therasphere Acrylic Shield Drop Test. (7 page(s), 12/23/1999)
• ML003686216 - Investigation Study Radiation Profile on a 20 GBq TheraSphere Dose Vial. (18 page(s), 12/24/1999)
• ML003686225 - Letter acknowledging receipt of January 19, 2000 application that requested a safety evaluation for a TheraSphere device. (2 page(s), 1/24/2000)
• ML003686238 - Letter forwarding copy of United States Food and Drug Administration approval letter for the Humanitarian Device Exemption application for TheraSphere Sealed Source and Device registration. (3 page(s), 12/17/1999)
• ML003686243 - Letter responding to 990702 application and letter dated 990813, requesting registration of Model TheraSphere device under the provisions of 10CFR32. (2 page(s), 11/23/1999)
• ML003686254 - REQUEST FOR WITHHOLDING INFORMATION FROM PUBLIC DISCLOSURE, MDS NORDION INC. MODEL THERASPHERE DEVICE. (2 page(s), 10/26/1999)
• ML003686260 - Request for Withdrawal of Documents from Public Discloure further to Device Approval Application for TheraSphere. (1 page(s), 9/29/1999)
• ML003686262 - Affidavit of ES Martell re attachments to letter dated 990813 - TheraSphere application for USNRC sealed Source and Device Registration. (3 page(s), 2/15/2000)
• ML003686263 - TheraSphere Application for USNRC Sealed Source and Device Registration. (2 page(s), 8/13/1999)
• ML003686265 - Certificate Number Q15066, certifying that Quality Management System of MDS Nordion Inc. Isotope Products Division Ontario, Canada have been assessed and registered as meeting the requirements of ISO 9001. (26 page(s), 11/11/1998)
• ML003686268 - Radiation protection - Sealed radioactive sources - General requirements and classification. (25 page(s), 12/31/1999)
• ML003686271 - TheraSphere Application for USNRC Sealed Source and Device Registration. (23 page(s), 8/12/1999)
• ML003686273 - E-mail following up to voice message on 9/2/99 regarding notarized affidavit. (2 page(s), 9/15/1999)
• ML003686278 - Request for Withdrawal of Documents from Public Disclosure further to Device Approval Application for Thera Sphere (2 page(s), 8/31/1999)
• ML003686281 - E-mail expressing thanks for the reminder regarding the affidavit. (2 page(s), 8/29/1999)
• ML003686298 - E-mail providing a reminder of the 8/11/99 telephone conversation that an affidavit is needed to treat Procedure Numbers 990601.SPE and 990602.SPE contained in application as proprietary information. (3 page(s), 8/27/1999)
• ML003686301 - Letter forwarding an application for sealed source and device evaluation and registration for TheraSphere, Yttrium-90 Glass Microspheres. (3 page(s), 7/2/1999)
• ML003686303 - E-mail informing that the acceptance review of #99-44 has been completed and found acceptable for the TheraSphere Device. (6 page(s), 8/1/1999)