FDA product code PMX: Absorbable Collagen Hemostatic Agent With Thrombin

PMX is the FDA product code for absorbable collagen hemostatic agent with thrombin. It is a Class III device, regulated under 21 CFR 878.4490 and reviewed by the General and Plastic Surgery panel. Devices under PMX reach the market by PMA; FDA lists no cleared 510(k)s for it. 4 PMA applications cite this product code. FDA has posted 2 recalls for PMX devices, 1 initiated in the last five years.

Definition

Intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

Classification

Recalls for PMX devices

2 product recalls in 2 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2023-12-06.

Frequently asked questions

What is FDA product code PMX?

PMX is the FDA product code for absorbable collagen hemostatic agent with thrombin. It is a Class III device, regulated under 21 CFR 878.4490 and reviewed by the General and Plastic Surgery panel.

What device class is PMX?

Class III, regulation 21 CFR 878.4490. Typical premarket route: PMA.

Have PMX devices been recalled?

Yes: 2 product recalls across 2 recall events; the most recent began 2023-12-06.

Next steps

• Run an FDA pathway report with predicate devices for product code PMX
• Run a recall and safety report across every PMX manufacturer
• Watch product code PMX for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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