FDA.reportPublic FDA data

AMS 800 Artificial Urinary Sphincter

Primary DI
00878953000794
Brand
AMS 800 Artificial Urinary Sphincter
Company
BOSTON SCIENTIFIC CORPORATION
Model
72400168
Catalog number
72400168
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
P000053003
P000053004
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
P000053003AMS SPHINCTER 800 URINARY CONTROL SYSTEMBoston Scientific Corp2001-06-14EZY
P000053004AMS 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
00878953000794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00878953000794008789530007948789530007940878953000794

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
Length8Centimeter

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
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14
08714729880318Rhythmia™ Mapping SystemM004RBLMR1002016-09-24
08714729938736RHYTHMIA HDx™M004RH20010M004RH200102017-05-03
08714729832089Rubicon™ 18H749392390180902016-09-24
08714729832096Rubicon™ 35H749392400350902016-09-24
08714729832102Rubicon™ 35H749392400351502016-09-24
08714729832119Rubicon™ 35H749392400350602016-09-24
08714729832126Rubicon™ 35H749392400351302016-09-24
08714729832133Rubicon™ 14H749392120141302016-09-24
08714729832140Rubicon™ 14H749392120141502016-09-24
08714729832157Rubicon™ 18H749392390181302016-09-24
08714729832164Rubicon™ 18H749392390181502016-09-24
00191506019563Rubicon™ ControlH749394321409A0H749394321409A02024-02-16
00191506019587Rubicon™ ControlH749394321413A0H749394321413A02024-02-16
00191506019600Rubicon™ ControlH749394321415A0H749394321415A02024-02-16
00191506019624Rubicon™ ControlH749394321809A0H749394321809A02024-02-16

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
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
00878953003177AMS 800 Artificial Urinary SphincterBOSTON SCIENTIFIC CORPORATIONEZY2014-09-24