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FDA PMA

Absorbable collagen hemostatic agent with thrombin

PMA Number: P990009 · 2025-11-13

ApplicantBaxter Healthcare Corp
Decision Date2025-11-13
PMA NumberP990009
Product CodePMX
Device ClassClass 3
Medical SpecialtyG
Regulation Number21 CFR 8
Advisory CommitteeSU

Device Summary

Absorbable collagen hemostatic agent with thrombin is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 2025-11-13. The device is classified under product code PMX. It was reviewed by the SU advisory panel.

Frequently Asked Questions

What is the Absorbable collagen hemostatic agent with thrombin?

Absorbable collagen hemostatic agent with thrombin is a medical device that received FDA 510(k) clearance on 2025-11-13. The listed applicant is Baxter Healthcare Corp.

When did Absorbable collagen hemostatic agent with thrombin receive FDA 510(k) clearance?

The clearance date for Absorbable collagen hemostatic agent with thrombin can be found in the official FDA records.

Who is the listed applicant for Absorbable collagen hemostatic agent with thrombin?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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

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