FDA.reportPublic FDA data

AMS 700™ with TENACIO™ Pump Accessory Kit

Primary DI
00191506021696
Brand
AMS 700™ with TENACIO™ Pump Accessory Kit
Company
BOSTON SCIENTIFIC CORPORATION
Model
72404850
Catalog number
72404850
Device description
Inflatable Penile Prosthesis Accessory Kit
Published
2024-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JCWProsthesis, penis, inflatable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCWProsthesis, Penis, InflatableGastroenterology, Urology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
N970012197

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
N970012197AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506021696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506021696001915060216961915060216960191506021696

GMDN Terms#

Term, Definition table
TermDefinition
Penile prosthesis implantation kitA collection of manual surgical instruments intended to be used during implantation of a penile prosthesis [for the treatment of erectile dysfunction (ED)]. The kit typically contains tools associated with insertion, measurement, and/or assembly of the implant; it does not contain any pharmaceuticals. This is a reusable device intended to be sterilized prior to use; it may contain disposable items that need to be replenished before reuse.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Kit
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
00191506021214AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021221AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021238AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021245AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021252AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021269AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021276AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021283AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021290AMS 700™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021306AMS 700™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021313AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021320AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021337AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021344AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021351AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021368AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021375AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021382AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021399AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021405AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021412AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021429AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021436AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021443AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021450AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021467AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021474AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021481AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021498AMS 700™ CXR TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021504AMS 700™ CXR TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26