FDA.reportPublic FDA data

TheraSphere™

Primary DI
00191506025328
Brand
TheraSphere™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00139552US0800
Catalog number
M00139552US0800
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
00191506025328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506025328001915060253281915060253280191506025328

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
00191506004583WATCHMAN FLX™ ProM635WU60200M635WU602002023-09-12
00191506004590WATCHMAN FLX™ ProM635WU60240M635WU602402023-09-12
00191506004606WATCHMAN FLX™ ProM635WU60270M635WU602702023-09-12
00191506004613WATCHMAN FLX™ ProM635WU60310M635WU603102023-09-12
00191506004620WATCHMAN FLX™ ProM635WU60350M635WU603502023-09-12
00191506004637WATCHMAN FLX™ ProM635WU60400M635WU604002023-09-12
08714729860488WATCHMAN FLX™M635WU50200M635WU502002020-07-28
08714729860495WATCHMAN FLX™M635WU50240M635WU502402020-07-28
08714729860501WATCHMAN FLX™M635WU50270M635WU502702020-07-28
08714729860518WATCHMAN FLX™M635WU50310M635WU503102020-07-28
08714729860525WATCHMAN FLX™M635WU50350M635WU503502020-07-28
00191506063146OPAL HDx™M004OPAL65110M004OPAL651102026-10-30
00191506063153OPAL HDx™M004OPAL63020M004OPAL630202026-10-30
00191506063191OPAL HDx™M004OPAL14010M004OPAL140102026-10-28
08714729840442SYNERGY™H7493926108220H74939261082202016-01-14
08714729840459SYNERGY™H7493926108250H74939261082502016-01-14
08714729840466SYNERGY™H7493926108270H74939261082702016-01-14
08714729840473SYNERGY™H7493926108300H74939261083002016-01-14
08714729840480SYNERGY™H7493926108350H74939261083502016-01-14
08714729840497SYNERGY™H7493926108400H74939261084002016-01-14

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
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