Product code PMX

Device name

Absorbable Collagen Hemostatic Agent With Thrombin

Medical specialty

General, Plastic Surgery

Device class

3

Regulation number

878.4490

Review panel

SU

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

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

Source

FDA openFDA device classification dataset