AMS 800 ARTIFICIAL URINARY SPHINCTER

FDA premarket approval P000053/S053 · decided 2015-01-28

Approval details

PMA number

P000053

Supplement

S053

Supplement type

Real-Time Process

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

AMS 800 ARTIFICIAL URINARY SPHINCTER

Generic name

Device, incontinence, mechanical/hydraulic

Applicant

Boston Scientific Corp

Date received

2014-11-03

Decision date

2015-01-28

Days to decision

86 days

Decision code

APPR

Product code

EZY

Advisory committee

Gastroenterology, Urology

Expedited review

No

Location

Marlboro, MA

Statement

APPROVAL FOR THE USE OF (I) THE ZONE OF INHIBITION (ZOI) AS THE SHELF LIFE INDICATION FACTOR AND TO CONSISTENTLY USE (II) A TWO YEAR SHELF LIFE FOR INHIBIZONE® (IZ) TREATED DEVICES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMS 800 ARTIFICIAL URINARY SPHINCTER (AMS 800). THE DEVICE IS USED TO TREAT URINARY INCONTINENCE DUE TO REDUCED OUTLET RESISTANCE (INTRINSIC SPHINCTER DEFICIENCY) FOLLOWING PROSTATE SURGERY. THE AMS 700 INFLATABLE PENILE PROSTHESIS (AMS 700) IS USED IN T

510(k) clearances by this applicant