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AMS 800 Artificial Urinary Sphincter

FDA premarket approval P000053/S110 · decided 2019-12-11

Approval details

PMA number
P000053
Supplement
S110
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
AMS 800 Artificial Urinary Sphincter
Generic name
Device, incontinence, mechanical/hydraulic
Applicant
Boston Scientific Corp
Date received
2019-11-12
Decision date
2019-12-11
Days to decision
29 days
Decision code
OK30
Product code
EZY
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
Statement
Software upgrade of the programmable logic controller for preconditioning and aeration cells used for Cycle 101, and utility update of the preconditioning cell steam supply from steam boilers to a pre-existing steam supply at the BSC Coventry, Rhode Islands facility.

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