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FDA PMA

Absorbable collagen hemostatic agent with thrombin

PMA Number: P170012 · 2026-04-28

ApplicantDilon Technologies, Inc.
Decision Date2026-04-28
PMA NumberP170012
Product CodePMX
Device ClassClass 3
Medical SpecialtyG
Regulation Number21 CFR 8
Advisory CommitteeSU

Device Summary

Absorbable collagen hemostatic agent with thrombin is a medical device manufactured by Dilon Technologies, Inc.. It received FDA Premarket Approval (PMA) on 2026-04-28 under PMA number P170012. The device is classified under FDA product code PMX. It was reviewed by the SU advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of G. It is regulated under 21 CFR Part 8. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Absorbable collagen hemostatic agent with thrombin?

Absorbable collagen hemostatic agent with thrombin is a medical device that received FDA Premarket Approval (PMA) on 2026-04-28. It is manufactured by Dilon Technologies, Inc.. The PMA number is P170012.

When did Absorbable collagen hemostatic agent with thrombin receive FDA PMA approval?

Absorbable collagen hemostatic agent with thrombin received FDA PMA approval on 2026-04-28, under approval number P170012.

What company makes Absorbable collagen hemostatic agent with thrombin?

Absorbable collagen hemostatic agent with thrombin is manufactured by Dilon Technologies, Inc..

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Absorbable collagen hemostatic agent with thrombin?

The FDA product code for Absorbable collagen hemostatic agent with thrombin is PMX.

What FDA device class is Absorbable collagen hemostatic agent with thrombin?

Absorbable collagen hemostatic agent with thrombin is classified as Class III by the FDA.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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