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  "documentTitle": "Penumbra, Inc. (PEN)",
  "authorId": "54_Spruce_Point_Capital",
  "authorName": "Spruce Point Capital Management",
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  "presentationDate": "2019-07-31 00:00:00",
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  "notes": "Highlights FDA approval documents for Medtronic React 68 and Stryker AXS Catalyst to show direct comparison to Penumbra's predicate devices.",
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      "kind": "callout",
      "text": "FDA clearance through the 510(k) pathway requires only evidence of \"substantial equivalency\" with a \"predicate device\" already on the market. That these aspiration catheters were cleared through direct comparison with Penumbra reinforces the commoditization of the industry and the ease with which competitors can enter the neurovascular aspiration catheter market.",
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      "kind": "callout",
      "text": "FDA clearance through the 510(k) pathway requires only evidence of “substantial equivalency” with a “predicate device” already on the market. That these aspiration catheters were cleared through direct comparison with Penumbra reinforces the commoditization of the industry and the ease with which competitors can enter the neurovascular aspiration catheter market.",
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      "text": "Stryker AXS Catalyst Distal Access Catheter FDA Approval document showing Table 1: Product Feature Comparison",
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      "text": "Medtronic React 68 FDA Approval document showing Device Comparison table",
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      "kind": "paragraph",
      "text": "Aspiration catheters designed for acute ischemic stroke treatment are cleared for clinical use by the FDA under the \"510(k) pathway.\" All medical devices must be cleared by the FDA through either a Premarket Approval (PMA) or Premarket Notification (PMN)...",
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      "kind": "title",
      "text": "510(k) Pathway Reduces Barriers To Entry",
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