Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of PromeplaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Promepla with 1 510(k) clearance. The most recent is a 510(k) clearance dated Oct 4, 2007: PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET.
| Date | Record | Source |
|---|---|---|
| Oct 4, 2007 | PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SETK071421 ยท FPA | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
