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AMS 800™ Artificial Urinary Sphincter, AMS 800™ Artificial Urinary Sphincter with InhibiZone™

FDA premarket approval P000053/S124 · decided 2022-04-01

Approval details

PMA number
P000053
Supplement
S124
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
AMS 800™ Artificial Urinary Sphincter, AMS 800™ Artificial Urinary Sphincter with InhibiZone™
Generic name
Device, incontinence, mechanical/hydraulic
Applicant
Boston Scientific Corp
Date received
2022-03-15
Decision date
2022-04-01
Days to decision
17 days
Decision code
OK30
Product code
EZY
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
Statement
Process change to the water bath monitoring requirements for assembly of the AMS 700 and AMS 800.

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