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AMS 800 Artificial Urinary Sphincter

FDA UDI

Class III (US FDA UDI)

by Boston Scientific

Identity

Trade Name
AMS 800 Artificial Urinary Sphincter FDA UDI
Generic Name
Urethral sphincter prosthesis, non-powered FDA UDI
Device Name
Pressure Regulating Balloon FDA UDI
Model / Reference
72400024 FDA UDI
Description
Pressure Regulating Balloon FDA UDI

Identifiers

Catalog Number
72400024 FDA UDI
Primary DI / UDI-DI
00878953000626 FDA UDI
PMA Number
P000053 FDA UDI
FDA Product Code
EZY FDA UDI
GMDN Term
Urethral sphincter prosthesis, non-powered FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
876.5280 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Urethral sphincter prosthesis, non-powered

AMS 800 Artificial Urinary Sphincter by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urethral sphincter prosthesis, non-powered.

Cleared under the same submission

P000053 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 21dbc560-7f88-401d-a124-c4e02f6c475c 36 fields · synced May 31, 2026