FDA-Device2014-02-26Class II

Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

Aesculap, Inc.
Hazard

The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.

Sold states
Worldwide Distribution - US Distribution including the states of AZ, MD, MA, WI, MI, MN, DE, KS, and FL., and the countries of Australia, Germany, Great Britain, Norway and Japan.
Affected count
79
Manufactured in
3773 Corporate Pkwy, Center Valley, PA, United States
Products
Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0989-2014

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