FDA.reportPublic FDA data

AMS Ambicor

Primary DI
00878953000985
Brand
AMS Ambicor
Company
BOSTON SCIENTIFIC CORPORATION
Model
72401454
Catalog number
72401454
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
00878953000985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00878953000985008789530009858789530009850878953000985

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
Length18Centimeter
Lumen/Inner Diameter14Millimeter
Outer Diameter14Millimeter

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
00802526629907CanGaroo®66BC05-10066BC05-1002026-05-27
00802526629914CanGaroo®66BC04-10066BC04-1002026-05-27
00802526629921CanGaroo®66BC02-10066BC02-1002026-05-27
00802526629938CanGaroo®66BC01-10066BC01-1002026-05-27
00802526629945CanGaroo®66BC03-10066BC03-1002026-05-27
00802526630002EluPro™66BE02-10066BE02-1002026-05-27
00802526630019EluPro™66BE03-10066BE03-1002026-05-27
08714729390275Maverick™ XLH74937909401502016-09-24
08714729390282Maverick™ XLH74937909402002016-09-24
08714729390299Maverick™ XLH74937909451502016-09-24
08714729390305Maverick™ XLH74937909452002016-09-24
08714729390312Maverick™ XLH74937909501502016-09-24
08714729390329Maverick™ XLH74937909502002016-09-24
08714729390336Maverick™ XLH74937909551502016-09-24
08714729390343Maverick™ XLH74937909552002016-09-24
08714729390350Maverick™ XLH74937909601502016-09-24
08714729390367Maverick™ XLH74937909602002016-09-24
08714729739258NAM0014416602016-09-24
08714729860488WATCHMAN FLX™M635WU50200M635WU502002020-07-28
08714729860495WATCHMAN FLX™M635WU50240M635WU502402020-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708932778671TitanColoplast A/SFHW2025-10-21
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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
00878953000992AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953001005AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953001012AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953001029AMS Ambicor BOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953001364AMS Ambicor RTE KitBOSTON SCIENTIFIC CORPORATIONFHW2014-09-24
00878953003023Proximal ToolAMERICAN MEDICAL SYSTEMS, INC.FHW2014-09-24