Atlas FDA

AMS 800 Artificial Urinary Sphincter (with and without InhibiZone)

FDA premarket approval P000053/S130 · decided 2024-10-08

Approval details

PMA number
P000053
Supplement
S130
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
AMS 800 Artificial Urinary Sphincter (with and without InhibiZone)
Generic name
Device, incontinence, mechanical/hydraulic
Applicant
Boston Scientific Corp
Date received
2023-05-18
Decision date
2024-10-08
Days to decision
509 days
Decision code
APPR
Product code
EZY
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
Statement
approval for material and manufacturing process changes to the pressure regulation balloon (PRB) component of the AMS 800 Artificial Urinary Sphincter

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