FDA.reportPublic FDA data

AMS 800 Artificial Urinary Sphincter

Primary DI
00878953005461
Brand
AMS 800 Artificial Urinary Sphincter
Company
BOSTON SCIENTIFIC CORPORATION
Model
720133-01
Catalog number
720133-01
Device description
Occlusive Cuff
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
P000053000
P000053024
P000053047
P000053050
P000053065
P000053067
P000053075
P000053083
P000053095
P000053096
P000053100
P000053101
P000053105
P000053112
P000053137

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000053000AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053024AMS 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
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
P000053100AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053101AMS 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
00878953005461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00878953005461008789530054618789530054610878953005461

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00802526613876LATITUDE® NXT646064602020-04-09
08714729893431ROTAPRO™ AdvancerH74939299A02018-07-11
08714729999560ROTAPRO™H749394671250H7493946712502020-07-01
08714729999577ROTAPRO™H749394671500H7493946715002020-07-01
08714729999584ROTAPRO™H749394671750H7493946717502020-07-01
08714729999591ROTAPRO™H749394672000H7493946720002020-07-01
08714729999607ROTAPRO™H749394672150H7493946721502020-07-01
08714729999614ROTAPRO™H749394672250H7493946722502020-07-01
08714729999621ROTAPRO™H749394672380H7493946723802020-07-01
08714729999638ROTAPRO™H749394672500H7493946725002020-07-01
00191506062620RIVOS™M00553900M005539002026-06-25
08714729050650Entry KitM001503500M0015035002016-01-29
08714729082026SteeroCath-Dx™M0042028BL02016-09-24
08714729085249Electrophysiology CableM00490002016-09-24
08714729114659Greenfield™M001503000M0015030002015-09-24
08714729114666Greenfield™M001503010M0015030102015-09-24
08714729124993Greenfield™M001505010M0015050102015-09-24
08714729270249Electrophysiology CableM004901AS02016-09-24
08714729270256Electrophysiology CableM004901BS02016-09-24
08714729334996Electrophysiology CableM004921B02016-09-24

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