Version Published Changed By Comment Actions
CURRENT (v. 13) Feb 02, 2023 22:08  
v. 12 Aug 22, 2022 23:18
v. 11 Oct 06, 2021 20:20 Updated precaution statement per FDA request to change "predicted value" to "estimated value" on 10/6
v. 10 Oct 06, 2021 20:03 Revised warning with wording from FDA that device has not been validated as substitute for invasive ICP monitoring methods
v. 9 Oct 06, 2021 19:57 Added statement about system being intended for use in adult patients 18+. Updated contraindication to match with Sensor User Guide. Per FDA request 10/6
v. 8 Sept 01, 2021 01:30
v. 7 Aug 18, 2021 12:56
v. 6 Aug 18, 2021 09:59
v. 5 Aug 18, 2021 09:59
v. 4 Aug 18, 2021 09:52
v. 3 Aug 17, 2021 23:56
v. 2 Aug 17, 2021 23:49
v. 1 Aug 13, 2021 18:35

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