Cultured Human Cell Skin Dressing

PFC · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: PFC
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: SU
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

Allogeneic skin cells cultured in vitro and combined with scaffold sheeting to act as a physical wound covering and provide biological components that interact with the wound, for treatment of skin ulcers.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown