FDA.reportPublic FDA data

AMS Ambicor

Primary DI
00878953001029
Brand
AMS Ambicor
Company
BOSTON SCIENTIFIC CORPORATION
Model
72401458
Catalog number
72401458
Device description
Inflatable Penile Prosthesis
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
FHWDevice, Impotence, Mechanical/Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHWDevice, Impotence, Mechanical/HydraulicGastroenterology, Urology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
N970012000
N970012094
N970012096
N970012110
N970012118
N970012121
N970012145
N970012151
N970012157
N970012158
N970012161

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
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
N970012121AMS 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
N970012151AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW
N970012157AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW
N970012158AMS 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00878953001029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00878953001029008789530010298789530010290878953001029

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
Length22Centimeter
Lumen/Inner Diameter15.5Millimeter
Outer Diameter15.5Millimeter

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
00191506049232Orbera™M00505670M005056702026-06-04
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24
08714729716204Ultraflex™ Esophageal NGM005138302015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05701780278034TitanColoplast A/SFHW2025-07-29
05708932768115Titan ClassicColoplast A/SFHW2024-10-29
05708932768139Titan ClassicColoplast A/SFHW2024-10-29
05708932768153Titan TouchColoplast A/SFHW2024-10-29
05708932768177Titan TouchColoplast A/SFHW2024-10-29
05701780276979TitanColoplast A/SFHW2023-05-11
05701780277006TitanColoplast A/SFHW2023-05-11
05708932072519Titan®Coloplast A/SFHW2017-10-16
05708932072526Titan®Coloplast A/SFHW2017-10-16
05708932072557Titan®Coloplast A/SFHW2017-10-16
05708932072564Titan®Coloplast A/SFHW2017-10-16
05708932072595Titan®Coloplast A/SFHW2017-10-16
05708932072601Titan®Coloplast A/SFHW2017-10-16
05708932072632Titan®Coloplast A/SFHW2017-10-16
05708932072649Titan®Coloplast A/SFHW2017-10-16
05708932661416TitanColoplast A/SFHW2017-06-21
05708932539104TitanColoplast A/SFHW2016-03-29
05708932539166TitanColoplast A/SFHW2016-03-29
00878953000947AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953000954AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953000961AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953000978AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953000985AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953000992AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953001005AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953001012AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953001364AMS Ambicor RTE KitBOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953003023Proximal ToolAMERICAN MEDICAL SYSTEMS, INC.FHW2014-09-24