ML25055A276
| ML25055A276 | |
| Person / Time | |
|---|---|
| Issue date: | 02/25/2025 |
| From: | Rolland J NRC/NMSS/DMSST/MSLB |
| To: | Mahilrajan T BWXT |
| References | |
| 25-10 | |
| Download: ML25055A276 (3) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 February 25, 2025 Mr. Tim Mahilrajan Director, Nuclear Regulatory & EHS BWXT Medical Ltd.
109 Ramsey Place Lynchburg, VA 24501
SUBJECT:
BWX TECHNOLOGIES, INCORPORATED AMENDED SEALED SOURCE AND DEVICE REGISTRATION CERTIFICATE NR-1490-D-101-S
Dear Mr. Mahilrajan:
This letter is in response to the BWX Technologies, Inc. application dated November 19, 2024, requesting an amendment to sealed source and device registration certificate NR-1490-D-101-S for the TheraSphere Y-90 Glass Microsphere System. We have completed our review of your request, and a copy of the amended registration certificate 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 by email at Joseph.Rolland@nrc.gov or by phone at (301) 415-4059.
Sincerely, 2/25/2025 X
Joseph Rolland Mechanical Engineer Signed by: JOSEPH ROLLAND Materials Safety and Licensing Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Registration Certificate NR-1490-D-101-S
ML25055A276 (*e-mail)
OFC NMSS/MSLB NMSS/MSLB NMSS/MSLB NMSS/MSLB NAME JRolland TBrockington LSepulveda JRolland DATE 2/24/2025 2/24/2025 2/25/2025 2/25/2025