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FDA PRODUCT CODE · CLASS III

PMX — Absorbable Collagen Hemostatic Agent With Thrombin

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

DEVICE CLASS
Class III
REGULATION
21 CFR 878.4490
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
pma: 2
0
RECALL ENTRIES

Recent clearances

P170012Dilon Technologies, Inc. · pma2026-04-28
P990009Baxter Healthcare Corp · pma2025-11-13

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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