R4 Ballot #1 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.3.0: R4 Ballot 2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R4 R3

V2-0330.cs.xml

Vocabulary Work Group

Maturity Level: N/A

Ballot Status: Informative

Raw XML (canonical form)

FHIR Value set/code system definition for HL7 v2 table 0330 ( Marketing Basis)

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="v2-0330"/> 
  <meta> 
    <profile value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/> 
  </meta> 
  <language value="en"/> 
  <text> 
    <status value="additional"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p> Marketing Basis</p> 

      <table class="grid">
        <tr> 
          <td> 
            <b> Code</b> 
          </td> 
          <td> 
            <b> Description</b> 
          </td> 
          <td> 
            <b> Comment</b> 
          </td> 
          <td> 
            <b> Version</b> 
          </td> 
        </tr> 
        <tr> 
          <td> 510E
            <a name="510E"> </a> 
          </td> 
          <td> 510 (K) exempt</td> 
          <td/>  
          <td> added v2.3</td> 
        </tr> 
        <tr> 
          <td> 510K
            <a name="510K"> </a> 
          </td> 
          <td> 510 (K)</td> 
          <td/>  
          <td> added v2.3</td> 
        </tr> 
        <tr> 
          <td> 522S
            <a name="522S"> </a> 
          </td> 
          <td> Post marketing study (522)</td> 
          <td/>  
          <td> added v2.3</td> 
        </tr> 
        <tr> 
          <td> PMA
            <a name="PMA"> </a> 
          </td> 
          <td> Premarketing authorization</td> 
          <td/>  
          <td> added v2.3</td> 
        </tr> 
        <tr> 
          <td> PRE
            <a name="PRE"> </a> 
          </td> 
          <td> Preamendment</td> 
          <td/>  
          <td> added v2.3</td> 
        </tr> 
        <tr> 
          <td> TXN
            <a name="TXN"> </a> 
          </td> 
          <td> Transitional</td> 
          <td/>  
          <td> added v2.3</td> 
        </tr> 
      </table> 

    </div> 
  </text> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-ballot-status">
    <valueString value="External"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="0"/> 
  </extension> 
  <url value="http://hl7.org/fhir/v2/0330"/> 
  <identifier> 
    <system value="urn:ietf:rfc:3986"/> 
    <value value="urn:oid:2.16.840.1.113883.18.201"/> 
  </identifier> 
  <version value="2.9"/> 
  <name value="v2 Marketing Basis"/> 
  <status value="active"/> 
  <experimental value="false"/> 
  <publisher value="HL7, Inc"/> 
  <contact> 
    <telecom> 
      <system value="url"/> 
      <value value="http://hl7.org"/> 
    </telecom> 
  </contact> 
  <description value="FHIR Value set/code system definition for HL7 v2 table 0330 ( Marketing Basis)"/> 
  <caseSensitive value="false"/> 
  <valueSet value="http://hl7.org/fhir/ValueSet/v2-0330"/> 
  <content value="complete"/> 
  <concept> 
    <code value="510E"/> 
    <display value="510 (K) exempt"/> 
    <designation> 
      <language value="nl"/> 
      <use> 
        <system value="http://hl7.org/fhir/CodeSystem/designation-usage"/> 
        <code value="display"/> 
      </use> 
      <value value="510 (K) vrijstelling"/> 
    </designation> 
  </concept> 
  <concept> 
    <code value="510K"/> 
    <display value="510 (K)"/> 
    <designation> 
      <language value="nl"/> 
      <use> 
        <system value="http://hl7.org/fhir/CodeSystem/designation-usage"/> 
        <code value="display"/> 
      </use> 
      <value value="510 (K)"/> 
    </designation> 
  </concept> 
  <concept> 
    <code value="522S"/> 
    <display value="Post marketing study (522)"/> 
    <designation> 
      <language value="nl"/> 
      <use> 
        <system value="http://hl7.org/fhir/CodeSystem/designation-usage"/> 
        <code value="display"/> 
      </use> 
      <value value="Post-marketingonderzoek (522)"/> 
    </designation> 
  </concept> 
  <concept> 
    <code value="PMA"/> 
    <display value="Premarketing authorization"/> 
    <designation> 
      <language value="nl"/> 
      <use> 
        <system value="http://hl7.org/fhir/CodeSystem/designation-usage"/> 
        <code value="display"/> 
      </use> 
      <value value="Pre-marketing autorisatie"/> 
    </designation> 
  </concept> 
  <concept> 
    <code value="PRE"/> 
    <display value="Preamendment"/> 
    <designation> 
      <language value="nl"/> 
      <use> 
        <system value="http://hl7.org/fhir/CodeSystem/designation-usage"/> 
        <code value="display"/> 
      </use> 
      <value value="Pre amendement"/> 
    </designation> 
  </concept> 
  <concept> 
    <code value="TXN"/> 
    <display value="Transitional"/> 
    <designation> 
      <language value="nl"/> 
      <use> 
        <system value="http://hl7.org/fhir/CodeSystem/designation-usage"/> 
        <code value="display"/> 
      </use> 
      <value value="Transitioneel"/> 
    </designation> 
  </concept> 
</CodeSystem>

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.