510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PMXClass III

Absorbable Collagen Hemostatic Agent With Thrombin

21 CFR 878.4490 / General, Plastic Surgery
FDA source (opens on fda.gov)

PMX is the FDA product code for Absorbable Collagen Hemostatic Agent With Thrombin, a class III device type, regulated under 21 CFR 878.4490. FDA's definition for this code reads: "Intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical". As of , FDA records hold no 510(k) clearances under this code and 2 recalls.

Classification record

Product code
PMX
Device name
Absorbable Collagen Hemostatic Agent With Thrombin
FDA definition
Intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Regulation
21 CFR 878.4490
Device class
Class III
Review panel
General, Plastic Surgery
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
2

Companies listing this code with FDA

Companies whose registered establishments list this code