FDA.reportPublic FDA data

TheraSphere™

Primary DI
00191506025434
Brand
TheraSphere™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00139552US1350
Catalog number
M00139552US1350
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
00191506025434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506025434001915060254341915060254340191506025434

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
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24
08714729284079EndoVive Low Profile Replacement ButtonM005628402016-09-24
08714729284086EndoVive Low Profile Replacement ButtonM005628502016-09-24
08714729821717Radial Jaw 4M005151802016-09-24
08714729821731Radial Jaw 4M005151902016-09-24
08714729821748Radial Jaw 4M005152002016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850014612153SIR-Spheres Y-90 resin microspheresSirtex Medical Inc.NAW2026-05-28
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
00191506025311TheraSphere™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
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