Device evidence · November 2, 2026
Read the device behind a PMA approval.
A facility’s FEI and a device’s PMA answer different questions. Follow the original approval to its documents, then compare the exact system and use with the item a supplier offers.
Worked example · historical U.S. decision
P160017 is the original MiniMed 670G record.
Open FDA’s P160017 record. Read the PMA number and the supplement field together: a search for this PMA can also return later supplements, with their own decision dates and changes.
- PMA / supplement
- P160017 / noneOriginal application; not a later S-number
- Device / product code
- MiniMed 670G SystemOZP · automated insulin dosing device system, single hormonal control
- Original decision
- September 28, 2016Approval (APPR); received June 16, 2016
- Applicant in this record
- Medtronic Minimed, Inc.Northridge, California, United States
Keep the original scope attached to the date.
The original approval-order statement describes the MiniMed 670G system for management of Type 1 diabetes in people fourteen years of age and older who require insulin, and states that the system requires a prescription. It lists the pump, Guardian Link (3) Transmitter, Guardian Sensor (3), One-Press Serter and Contour NEXT Link 2.4 Glucose Meter as system components.
This is a reading example of the 2016 original decision, not current treatment guidance. FDA warns on this record that supplements may change the device description, function or indication, and that the original labeling may not be the latest version. Do not use the historical age range to decide current eligibility.
Source: U.S. FDA PMA record and openFDA PMA data, consulted November 2, 2026. API snapshot: October 26, 2026. Unit: one original application record, not a count of suppliers or products on sale. California is the applicant location in this record; this U.S. approval does not establish authorization in another country.
Three documents, three reading tasks
Choose the evidence that answers your question.
The original record links these documents. Open them from FDA and keep the document’s date and the relevant page with your notes; the links alone do not establish a match to a quotation.
Approval Order
Start with the decision and its stated scope or conditions. Keep it with the original decision date.
Open FDA approval order (PDF)Safety and Effectiveness
Use the summary to investigate the device description and the evidence supporting that application.
Open FDA SSED (PDF)Labeling
Compare the described system, use and limitations. This link is the original labeling, not proof of today’s version.
Open original FDA labeling (PDF)
Then check later changes. Return to the original record’s Supplements list. Follow records relevant to the offered model and use; a supplement date is not the original approval date. Save which records you checked. This guide does not determine which supplement applies to a current product.
Two evidence columns
A PMA number is the start of the comparison.
- FDA recordOriginal PMA and any relevant supplements
- Supplier evidenceThe exact PMA and supplement claimed, plus the document linking that decision to the offered version. Do not accept only the newest date in a search result.
- FDA recordNamed system and components
- Supplier evidenceModel, catalog number, software version and included components. A related brand or component name does not identify the entire approved system.
- FDA recordIndication, population and limits
- Supplier evidenceThe exact advertised use and applicable current labeling. Record a mismatch or missing connection instead of expanding the original indication.
“MiniMed system — FDA approved, see P160017.”
The quotation omits the model and components. Write: “Original PMA located; offered configuration and applicable labeling unresolved.” Ask for the exact model/configuration and evidence connecting it to the cited record and relevant later changes. Do not turn a family name into a confirmed product match.
A repeatable evidence note
Leave the decision trail, including the gaps.
- Record the PMA number, supplement identifier, applicant, device name and original decision date.
- Save the official record and document URLs, retrieval date, and page or section supporting each comparison.
- Keep the quotation’s model, configuration and intended use beside the source wording. Mark missing information as unresolved.
- Check relevant supplements and current labeling before relying on the original documents. A failed source check means the status is unknown, not that approval is absent.
Use the supplier evidence worksheet to assemble the packet. For a K-number, use the 510(k) summary guide. Check recall records separately; an approval record does not resolve recall status or the identity of a current seller.
Primary sources and scope
Historical decision, dated consultation.
- FDA: original P160017 record — number, applicant, dates, product code, approval-order statement, document links and warning about later supplements.
- openFDA: P160017 application and supplement records — snapshot October 26, 2026. The example selects the record with an empty supplement number, not the first returned result.
- FDA: Premarket Approval (PMA) — background on the FDA review of safety and effectiveness, not sector statistics or a supplier endorsement.
Consulted November 2, 2026. FDA pages were read through a text representation; the API was queried directly. The PDF links were identified in the original record; this example does not claim an independent review of every PDF or later supplement. No current supplier, inventory, recall status or worldwide authorization has been verified.