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However, the PRMR Hospital Recommendation Group members expressed concerns about lack of testing in the ASC setting given differences between HOPDs as a hospital setting (where testing of the Information Transfer PRO-PM was conducted) and ASCs

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We stated that the addition of the dry coating of sodium hyaluronate and sodium alginate to the Axoguard Nerve Protector TM appears to be the distinguishing feature of the device that is the subject of this application