FDA.reportPublic FDA data

AMS 700™ CX TENACIO™ Pump

Primary DI
00191506021368
Brand
AMS 700™ CX TENACIO™ Pump
Company
BOSTON SCIENTIFIC CORPORATION
Model
72404435
Catalog number
72404435
Device description
Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic
Published
2024-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
N970012211

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
N970012197AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW
N970012211AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESBoston Scientific Corp1998-11-02JCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506021368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506021368001915060213681915060213680191506021368

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
Length0

Regulatory Flags#

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506063191OPAL HDx™M004OPAL14010M004OPAL140102026-10-28
08714729840442SYNERGY™H7493926108220H74939261082202016-01-14
08714729840459SYNERGY™H7493926108250H74939261082502016-01-14
08714729840466SYNERGY™H7493926108270H74939261082702016-01-14
08714729840473SYNERGY™H7493926108300H74939261083002016-01-14
08714729840480SYNERGY™H7493926108350H74939261083502016-01-14
08714729840497SYNERGY™H7493926108400H74939261084002016-01-14
08714729840503SYNERGY™H7493926112220H74939261122202016-01-14
08714729840510SYNERGY™H7493926112250H74939261122502016-01-14
08714729840527SYNERGY™H7493926112270H74939261122702016-01-14
08714729840534SYNERGY™H7493926112300H74939261123002016-01-14
08714729840541SYNERGY™H7493926112350H74939261123502016-01-14
08714729840558SYNERGY™H7493926112400H74939261124002016-01-14
08714729840565SYNERGY™H7493926116220H74939261162202016-01-14
08714729840572SYNERGY™H7493926116250H74939261162502016-01-14
08714729840589SYNERGY™H7493926116270H74939261162702016-01-14
08714729840596SYNERGY™H7493926116300H74939261163002016-01-14
08714729840602SYNERGY™H7493926116350H74939261163502016-01-14
08714729840619SYNERGY™H7493926116400H74939261164002016-01-14
08714729840626SYNERGY™H7493926120220H74939261202202016-01-14

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
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00191506021245AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021252AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
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00191506021412AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
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