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AMS 800 Artificial Urinary Sphincter with and without InhibiZone Treatment

FDA premarket approval P000053/S117 · decided 2020-10-30

Approval details

PMA number
P000053
Supplement
S117
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
AMS 800 Artificial Urinary Sphincter with and without InhibiZone Treatment
Generic name
Device, incontinence, mechanical/hydraulic
Applicant
Boston Scientific Corp
Date received
2020-09-29
Decision date
2020-10-30
Days to decision
31 days
Decision code
OK30
Product code
EZY
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
Statement
Modification to the manufacturing process for the outer and inner Tyvek packaging pre-printed tray lids components.

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