Read what a PMA supplement actually changed.

Three identifiers to keep together

Original decision → specific change → offered device.

1. 01

   Original PMA

   Save the original P-number and its decision date. Use the original PMA guide for the starting device and documents.

2. 02

   Exact supplement

   Save the S-number, decision date, type, reason and decision statement. Read the change itself; do not infer it from the device family name.

3. 03

   Offered configuration

   Compare the quotation’s model, component, version and use with the change. Missing evidence stays unresolved, even when the PMA number matches.

A supplement is not the same as an amendment. FDA describes an amendment as additional information for a pending application or supplement. This guide reads published supplement records; it does not advise which submission a manufacturer must file.

Worked example · historical U.S. records

Same P-number. Different changes.

These two records belong to P160017, the original MiniMed 670G application approved September 28, 2016. They illustrate why the S-number matters. They are not a complete history or a determination of today’s labeling.

Read dates, not S-number order. S004’s decision (December 22, 2016) predates S003’s (February 2, 2017). Sorting by S-number would give the wrong decision chronology for this pair.

U.S. FDA openFDA PMA records, snapshot October 26, 2026; consulted November 3, 2026. Unit: two historical supplement records, plus the original application for context. Applicant: Medtronic Minimed, Inc., Northridge, California, United States. This location is record context, not a market statistic. U.S. decisions do not establish authorization in another country.

Fictional quotation · not a real seller

“Latest FDA approval” leaves a question open.

Suppose a quotation says “MiniMed system — updated FDA approval: P160017/S004” but omits the model. The record located is a study protocol decision. It does not, by itself, connect the offered configuration to a device change.

What you can document

P160017/S004 was located. The decision statement concerns a post-approval study protocol.

What remains unresolved

The offered model/version, the change relevant to that configuration and the applicable current labeling.

What to request

The exact model and version, plus the official record and document section supporting the particular change claimed. Keep the original decision and relevant supplements together.

Use a precise evidence note: “Supplement located; claimed model change not established by this record.” A matching P-number is useful context, not a completed comparison.

A reproducible handoff

Keep each change attached to its evidence.

• Save original PMA + S-number, applicant, device name, decision date and statement.
• Record which component, model or use the statement actually addresses; retain source wording beside your interpretation.
• Save official URLs, retrieval date and relevant document pages. Check applicable current labeling and later records before relying on a historical example.
• If an FDA page fails to load, mark that check unavailable. An API record or failed page does not prove current seller identity, inventory, recall status or absence of later changes.

Continue with the supplier evidence worksheet or the recall reading guide. For a facility identifier, use the existing FEI lookup; facility and device evidence answer different questions.

Primary sources and limits

Historical records, with an explicit consultation date.

• openFDA: P160017 application and supplement records — queried directly; the examples select exact supplement numbers S003 and S004, not the first search result. Snapshot October 26, 2026.
• FDA: PMA Supplements and Amendments — explains changes and amendments, read through a text representation. Regulatory guidance is not sector statistics.
• FDA: original P160017 record, with S003 and S004 — official record destinations. Both supplement pages were read through text representations and checked against the direct FDA API. The original record’s text retrieval was blocked; original fields were checked in the API. No independent review of PDFs or the full supplement history is claimed.

Consulted November 3, 2026. Informational reading example only; no clinical recommendation, current product eligibility, complete supplement review, seller endorsement or worldwide authorization is established.