FDA.reportPublic FDA data

Solyx™ SIS System

Primary DI
08714729774044
Brand
Solyx™ SIS System
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0068507000
Device description
SIS System
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PAHmesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAHMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-SlingGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729784784PackageGS15Not in Commercial Distribution
08714729774044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729784784087147297847848714729784784
08714729774044087147297740448714729774044

GMDN Terms#

Term, Definition table
TermDefinition
Female stress urinary incontinence surgical mesh-sling, synthetic polymerA woven/knitted or porous strip of material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (via transobturator, transvaginal, retropubic or suprapubic approach) to support the urethra for the treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). It typically includes an integral adjustment suture which may contain bioabsorbable polymer materials. It may also be referred to as a tape or subfascial hammock. Disposable devices associated with implantation may be supplied with the mesh-sling.

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
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
08437007606058Needleless SlingDESARROLLO E INVESTIGACION MEDICA ARAGONESA SLPAH2020-10-19
00890594000957Desara One Caldera Medical, Inc.PAH2020-02-25
00890594000971Desara One Caldera Medical, Inc.PAH2020-02-25
08714729961901Solyx™ BlueBOSTON SCIENTIFIC CORPORATIONPAH2018-06-13
28032919892120T-SLINGHERNIAMESH SRLPAH2016-08-05
00814723020036MiniArcENDO PHARMACEUTICALS INC.PAH2015-10-24
00814723020104MiniArcENDO PHARMACEUTICALS INC.PAH2015-10-24
00814723020364MiniArcENDO PHARMACEUTICALS INC.PAH2015-10-24
05708932467407AltisColoplast A/SPAH2015-10-22
08714729784784Solyx™ SIS System BOSTON SCIENTIFIC CORPORATIONPAH2015-09-24