Identify Issues in FDA Pre-Submission Package for Novel Thrombectomy Device — Issue Memorandum

Healthcare & Life Sciencesmedical-devices510(k)pre-submissionCDRHregulatory-compliancelife-sciencesissue-memorandum

Instructions

Review the attached draft Pre-Submission package for a catheter-based thrombectomy device and prepare a prioritized issue memorandum. Output: `presub-issue-memorandum.docx`.

Work type: Review — Mark up, redline, or critique an existing document.

Deliverables (1)

presub-issue-memorandum.docx

Reference documents (7)

DOCX
clinical-study-synopsis.docx
49.6 KB
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DOCX
device-description-predicate-comparison.docx
53.3 KB
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DOCX
draft-ifu-vasculear-3000.docx
52.3 KB
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EML
internal-email-chain-reg-strategy.eml
17.4 KB
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DOCX
presub-cover-letter.docx
43.2 KB
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DOCX
proposed-testing-plan.docx
59.2 KB
Open
DOCX
thrombex-200-510k-summary.docx
48.6 KB
Open

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Rubric (47)

Each criterion is judged independently as pass or fail. The task scores 1.0 only if every criterion passes.

47 of 47 criteria