FDA.reportPublic FDA data

AMS 800 Artificial Urinary Sphincter

Primary DI
00878953005652
Brand
AMS 800 Artificial Urinary Sphincter
Company
BOSTON SCIENTIFIC CORPORATION
Model
720157-01
Catalog number
720157-01
Device description
Occlusive Cuff with InhibiZone
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EZYDevice, Incontinence, Mechanical/Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZYDevice, Incontinence, Mechanical/HydraulicGastroenterology, Urology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000053024
P000053041
P000053047
P000053050
P000053053
P000053054
P000053065
P000053067
P000053075
P000053083
P000053095
P000053096
P000053103
P000053104
P000053105
P000053112
P000053137

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000053024AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053041AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053047AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053050AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053053AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053054AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053065AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053067AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053075AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053083AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053095AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053096AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053103AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053104AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053105AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053112AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053137AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00878953005652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00878953005652008789530056528789530056520878953005652

GMDN Terms#

Term, Definition table
TermDefinition
Urethral sphincter prosthesis systemA sterile implantable assembly of devices indicated for incontinence and intended to support or replace a natural urethral sphincter. It is a hydraulically-operated system typically consisting of a single or double cuff to surround the urethra, a reservoir for the hydraulic liquid, e.g., saline with/without radiopacifier, and a manually driven pump. It is made of a non-bioabsorbable polymeric material.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.5Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506062514Navigator™M0062504000M00625040002026-09-25
00191506062521Navigator™M0062504010M00625040102026-09-25
00191506062538Navigator™M0062504020M00625040202026-09-25
00191506062545Navigator™M0062504100M00625041002026-09-25
00191506062552Navigator™M0062504110M00625041102026-09-25
00191506062569Navigator™M0062504120M00625041202026-09-25
00191506062576Navigator™M0062504200M00625042002026-09-25
00191506062583Navigator™M0062504210M00625042102026-09-25
00191506062590Navigator™M0062504220M00625042202026-09-25
00802526531101ENDOTAK RELIANCE® S013701372014-09-24
00802526531118ENDOTAK RELIANCE® S013801382014-09-24
00802526531125ENDOTAK RELIANCE®015701572014-09-24
00802526531132ENDOTAK RELIANCE®015801582014-09-24
00191506047832NAM001AJAEC0100M001AJAEC01002026-09-22
00191506063214OPAL HDx™M004OPAL11020M004OPAL110202026-09-20
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00878953000602AMS 800 Artificial Urinary SphincterAMERICAN MEDICAL SYSTEMS, INC.EZY2014-09-24
00878953000619AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953000626AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953000633AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953000640AMS 800 Artificial Urinary SphincterAMERICAN MEDICAL SYSTEMS, INC.EZY2014-09-24
00878953000657AMS 800 Artificial Urinary SphincterAMERICAN MEDICAL SYSTEMS, INC.EZY2014-09-24
00878953000688AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953000718AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953000725AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953000732AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953000749AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953000756AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953000763AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953000770AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953000787AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953000794AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953000800AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953000817AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953000824AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953001036AMS 800 Artificial Urinary SphincterAMERICAN MEDICAL SYSTEMS, INC.EZY2014-09-24
00878953003078AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953003085AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953003092AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953003108AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953003115AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953003122AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953003139AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953003146AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953003153AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24
00878953003160AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24