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IFU & Protocol Documents

CONFORM IDE Trial NCT05147792

CLAAS System IFU Rev. L

22July2025

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Protocol Rev. M

30Apr2025

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Protocol Synopsis Rev. M

30Apr2025
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Memos to File

CONFORM Study -Use of Electronic Informed Consent (eConsent)

05Dec2025
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CONFORM Study – Pre-Discharge TTE

05Dec2025
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CONFORM Study -Verbal Informed Consent

05Dec2025
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Screenshot 2025-08-15 at 9.10.47 AM

Inclusion / Exclusion Criteria Card Protocol Rev. M

For The CONFORM Pivotal Trial with The CLAAS® Device 

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Archived IFU & Redline Documents

IFU Rev. J

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IFU Rev. E to J Redlines

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IFU Rev. J to K Redlines

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IFU Rev. K to L Redlines

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IFU Rev. K to M Redlines

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CONFORM Protocol Summary of Changes Rev K to Rev L to Rev M

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CAUTION: Investigational Device
Limited by federal (or United States) law to investigational use. Outside the United States, the device is intended exclusively for clinical investigation. Not approved for commercial use.