Atlas FDA

AMS SPHINCTER 800 URINARY PROSTHESIS

FDA premarket approval P000053/S004 · decided 2004-05-07

Approval details

PMA number
P000053
Supplement
S004
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
AMS SPHINCTER 800 URINARY PROSTHESIS
Generic name
Device, incontinence, mechanical/hydraulic
Applicant
Boston Scientific Corp
Date received
2004-03-11
Decision date
2004-05-07
Days to decision
57 days
Decision code
APPR
Product code
EZY
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
Statement
APPROVAL FOR A NEW MANUFACTURING PROCEDURE TO PRODUCE THE CUFF BACKING, A DESIGN CHANGE TO THE THICKNESS OF THE CUFF BACKING, A MATERIAL CHANGE IN THE SILICONE, AND A PROMOTIONAL CLAIM REGARDING THE CUFF WEAR CHARACTERISTICS OF THE MODIFIED DESIGN.

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