← FDA Medical Device Classifications
Absorbable Collagen Hemostatic Agent With Thrombin
PMX · Class III — High Risk (PMA approval required, life-sustaining) · General, Plastic Surgery · 21 CFR 878.4490
Classification
- FDA Product Code
PMX- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 878.4490
- Review panel
- SU
- Medical specialty
- General, Plastic Surgery
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
Intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 7
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown