PMX — Absorbable Collagen Hemostatic Agent With Thrombin Class III
FDA product code PMX covers "Absorbable Collagen Hemostatic Agent With Thrombin", a Class III medical device regulated under 21 CFR 878.4490. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants.
Classification Details
- Product Code
- PMX
- Device Class
- Class III
- Regulation Number
- 878.4490
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
Intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.