FDA-Device2018-03-07Class II
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Aesculap Implant Systems LLC
Hazard
A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
Sold states
US Distribution to PA.
Affected count
2
Manufactured in
3773 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0809-2018Don't want to check this manually?
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