Aksys Ltd.

Recipient:Aksys Ltd..
Product:Aksys PHD Personal Hemodialysis System
Date: 6/806

Our records do not show that you obtained marketing clearance or approval before you began offering your device for sale with a modified treatment length. The device was cleared via a premarket notification (510(k)) _____, on _____, with a specified treatment length of _____ using a _____. Your current website indicates a modified treatment length of _____ using a _____. Such a change would require significant modifications to the design and software of the device, and could affect the safety due to _____ and/or _____ quality issues. FDA will evaluate this information and decide whether your product may be legally marketed.

Issuer: Center for Devices and Radiological Health (CDRH)

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.