France CONFORM Pivotal Trial Portal

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.

ClinicalTrials.gov ID NCT05147792

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Site Startup Documents

Protocols & ICF Documents

Protocol Rev M.

Protocol Synopsis Rev M.

CONFORM Pivotal TEE imaging Acquisition Protocol V6.0

CONFORM Angio Protocol V1.0

Protocol Synopsis Rev M.

CONFORM Pivotal TEE imaging Acquisition Protocol V. 6.0

Real Time Analytics Dashboard

Real Time Analytics Dashboard

Real Time Analytics Dashboard

Budget & CTA Documents

CONFORM Pivotal Payment Terms Template V6.1

CONFORM Pivotal Payment Terms Template V6.1

CONFORM Pivotal Payment Terms Template V6.1

CONFORM Pivotal Payment Terms Template V6.1

CONFORM Pivotal Payment Terms Template V6.1

CONFORM Pivotal Payment Terms Template V6.1

CONFORM Pivotal Payment Terms Template V6.1

CONFORM Pivotal Payment Terms Template V6.1

CONFORM Pivotal Payment Terms Template V6.1

CONFORM Pivotal Payment Terms Template V6.1

CONFORM Pivotal Payment Terms Template V6.1

CONFORM Pivotal Payment Terms Template V6.1

FDA & CMS Approval Documents

CED Approval CONFORM IDE Trial Letter

FDA Approval, Supplement

FDA Approval, Supplement 033

FDA Approval Letter to Resume CONFORM IDE Trial

Instructions for Use Documents

CLAAS System IFU Rev L.

Patient Facing Documents

CLAAS Device Demonstration Memo

Conformal Clinical Trial Poster Rev C.

Conformal Medical Implant Card Rev B.

Conformal Patient Brochure Rev C.

Conformal Patient Magnet Rev A.

Implant Flipbook CONFORM Pivotal Rev A.

ClinicalTrials.gov ID NCT05147792