FDA.reportPublic FDA data

TheraSphere™

Primary DI
00191506025311
Brand
TheraSphere™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00139552US0750
Catalog number
M00139552US0750
Device description
YTTRIUM-90 GLASS MICROSPHERES
Published
2026-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NAWMicrospheres radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAWMicrospheres RadionuclideUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200029000TheraSphereBoston Scientific Corporation2021-03-17NAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506025311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506025311001915060253111915060253110191506025311

GMDN Terms#

Term, Definition table
TermDefinition
Manual brachytherapy source, permanent implantA device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means of an applicator using either fluoroscopic or endoscopic guidance. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506021214AMS 700 LGX™ TENACIO™ Pump72404400724044002024-01-26
00191506021221AMS 700 LGX™ TENACIO™ Pump72404401724044012024-01-26
00191506021238AMS 700 LGX™ TENACIO™ Pump72404402724044022024-01-26
00191506021245AMS 700 LGX™ TENACIO™ Pump72404403724044032024-01-26
00191506021252AMS 700 LGX™ TENACIO™ Pump72404405724044052024-01-26
00191506021269AMS 700 LGX™ TENACIO™ Pump72404406724044062024-01-26
00191506021276AMS 700 LGX™ TENACIO™ Pump72404407724044072024-01-26
00191506021283AMS 700 LGX™ TENACIO™ Pump72404408724044082024-01-26
00191506021290AMS 700™ TENACIO™ Pump72404420724044202024-01-26
00191506021306AMS 700™ TENACIO™ Pump72404429724044292024-01-26
00191506021313AMS 700™ CX TENACIO™ Pump72404430724044302024-01-26
00191506021320AMS 700™ CX TENACIO™ Pump72404431724044312024-01-26
00191506021337AMS 700™ CX TENACIO™ Pump72404432724044322024-01-26
00191506021344AMS 700™ CX TENACIO™ Pump72404433724044332024-01-26
00191506021351AMS 700™ CX TENACIO™ Pump72404434724044342024-01-26
00191506021368AMS 700™ CX TENACIO™ Pump72404435724044352024-01-26
00191506021375AMS 700™ CX TENACIO™ Pump72404436724044362024-01-26
00191506021382AMS 700™ CX TENACIO™ Pump72404437724044372024-01-26
00191506021399AMS 700™ CX TENACIO™ Pump72404438724044382024-01-26
00191506021405AMS 700™ CX TENACIO™ Pump72404439724044392024-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850014612153SIR-Spheres Y-90 resin microspheresSIRTEX MEDICAL PTY LTDNAW2026-05-28
00191506025229TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025236TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025243TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025250TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025267TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025274TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025281TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025298TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025304TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025328TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025335TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025342TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025359TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025366TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025373TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025380TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025397TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025403TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025410TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025427TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025434TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025441TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025458TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025465TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025472TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025489TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025496TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025502TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01
00191506025519TheraSphere™BOSTON SCIENTIFIC CORPORATIONNAW2026-03-01