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PMA P000053S133

Device
AMS 800™ Artificial Urinary Sphincter (AUS)
Applicant
Boston Scientific Corp
PMA number
P000053
Supplement
S133
Product code
EZY
Decision date
2023-12-11
Classification
Gastroenterology, Urology
Generic name
Device, incontinence, mechanical/hydraulic
Approval order statement
a change to the process and equipment for mixing the silicone elastomer material used for extrusion of the kink resistant tubing (KRT) component of the AMS 700 IPP and AMS 800 AUS devices at Boston Scientific Corporation (BSC) St. Paul

Current openFDA PMA Record#

Device
AMS 800™ Artificial Urinary Sphincter (AUS)
Applicant
Boston Scientific Corp
PMA number
P000053
Supplement
S133
Product code
EZY
Generic name
Device, incontinence, mechanical/hydraulic
Decision date
2023-12-11
Decision code
OK30
Date received
2023-11-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a change to the process and equipment for mixing the silicone elastomer material used for extrusion of the kink resistant tubing (KRT) component of the AMS 700 IPP and AMS 800 AUS devices at Boston Scientific Corporation (BSC) St. Paul