ML22167A203
| ML22167A203 | |
| Person / Time | |
|---|---|
| Issue date: | 06/27/2022 |
| From: | Thi Herrera NRC/NMSS/DMSST |
| To: | Mahilrajan T BWXT Medical, Ltd |
| Herrera T | |
| Shared Package | |
| ML22040A379 | List: |
| References | |
| SSD 22-07 | |
| Download: ML22167A203 (3) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 June 27, 2022 Mr. Tim Mahilrajan Senior Manager - Nuclear Regulatory & EHS BWXT Medical, Ltd.
109 Ramsey Place Lynchburg, VA 24501
SUBJECT:
BWXT MEDICAL, LTD. AMENDED SEALED SOURCE AND DEVICE REGISTRATION CERTIFICATE NR-1490-D-101-S
Dear Mr. Mahilrajan:
This is in response to the BWXT Medical Ltd. (BWXT Medical) letter dated February 8, 2022, requesting an amendment to Sealed Source and Device Registration Certificate NR-1490-D-101-S to expand the use of TheraSpheres for the treatment of glioblastoma in clinical trials. We have completed our review of your request, and a copy of the amended registration NR-1490-D-101-S is enclosed.
Please be advised that you must manufacture and distribute any registered product in accordance with the statements and representations contained in your application, with enclosures thereto, and the information set out in your registration certificates. A registration certificate is meant to indicate that your product is acceptable for licensing purposes but does not authorize distribution or possession of radioactive material. As a general rule, you must request and obtain an amendment to the certificate before you make changes or modifications to the information submitted to obtain the certificate.
Please read over the registration certificate in its entirety and notify us immediately of any errors or omissions.
You are obligated to notify us promptly in writing if you decide to no longer manufacture, distribute, or offer service support for the product.
T. Mahilrajan 2
If you have any questions, please contact me at Tomas.Herrera@nrc.gov or at (301) 415-7138.
Sincerely, 6/27/2022 X
Tomas Herrera Team Leader Signed by: Tomas E. Herrera Tomas Herrera, Team Leader Materials Safety and Tribal Liaison Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Amended Registration NR-1490-D-101-S
ML22167A203 *concurrence via email OFC NMSS/MSTB NMSS/MSTB NMSS/MSTB NAME THerrera LSepulveda THerrera DATE 6/24/2022 6/24/2022 6/27/2022