FDA.reportPublic FDA data

AMS 700 CX

Primary DI
00878953003252
Brand
AMS 700 CX
Company
BOSTON SCIENTIFIC CORPORATION
Model
72404171
Catalog number
72404171
Device description
Inflatable Penile Prosthesis, 2 Cylinders, InhibiZone treated
Published
2014-09-25
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
JCWProsthesis, Penis, Inflatable

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
N970012000
N970012094
N970012096
N970012102
N970012103
N970012110
N970012118
N970012128
N970012145
N970012150
N970012161
N970012163
N970012177
N970012196
N970012206

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
N970012000AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW
N970012094AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW
N970012096AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW
N970012102AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW
N970012103AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW
N970012110AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW
N970012118AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW
N970012128AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW
N970012145AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW
N970012150AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW
N970012161AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW
N970012163AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW
N970012177AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW
N970012196AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW
N970012206AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00878953003252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00878953003252008789530032528789530032520878953003252

GMDN Terms#

Term, Definition table
TermDefinition
Inflatable penile prosthesisAn inflatable/deflatable sterile device designed of several interconnected components intended to be surgically implanted in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. It is available in a variety of designs and materials and typically consists of: 1) one or two inflatable cylinders implanted into the corpora cavernosa of the penis; 2) a subcutaneous manual pump bulb implanted into the scrotum; 3) a reservoir containing fluid (e.g., saline with/without radiopacifier) implanted in the abdomen; and 4) kink-resistant tubing that connect the component parts.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Centimeter
Outer Diameter12Millimeter

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
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
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