AMS 800 Artificial Urinary Sphincter with InhibiZone

FDA premarket approval P000053/S104 · decided 2020-02-13

Approval details

PMA number

P000053

Supplement

S104

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

AMS 800 Artificial Urinary Sphincter with InhibiZone

Generic name

Device, incontinence, mechanical/hydraulic

Applicant

Boston Scientific Corp

Date received

2019-05-23

Decision date

2020-02-13

Days to decision

266 days

Decision code

APPR

Product code

EZY

Advisory committee

Gastroenterology, Urology

Expedited review

No

Location

Marlboro, MA

Statement

Approval for the use of an improved UPLC method for release and stability, minor updates to microbial Zone of Inhibition method and other associated updates to the Sub System and System level Product Specifications for the AMS 700 Inflatable Penile Prosthesis with InhibiZone and AMS 800 Artificial Urinary Sphincter with InhibiZone Treatment to bring to current standards.

510(k) clearances by this applicant