| Title: | before you begin | |
|---|---|---|
| Owner: | Claudio Menegusso | |
| Creator: | Claudio Menegusso | Aug 13, 2021 |
| Last Changed by: | Claudio Menegusso | Feb 02, 2023 |
| Tiny Link: (useful for email) | https://brain4care.atlassian.net/wiki/x/1ptudw | |
| Export As: | Word · PDF | |
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| Time | Editor | |
|---|---|---|
| Feb 02, 2023 22:08 | Claudio Menegusso | View Changes |
| Aug 22, 2022 23:18 | Claudio Menegusso | View Changes |
| Oct 06, 2021 20:20 | Connie Qiu | View Changes |
| Updated precaution statement per FDA request to change "predicted value" to "estimated value" on 10/6 | ||
| Oct 06, 2021 20:03 | Connie Qiu | View Changes |
| Revised warning with wording from FDA that device has not been validated as substitute for invasive ICP monitoring methods | ||
| Oct 06, 2021 19:57 | Connie Qiu | |
| 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 | ||