Device, Dermal Replacement
Basic Information
- Device Name
- Device, Dermal Replacement
- Trade Name
- INTEGRA DERMAL REGENERATION TEMPLATE, INTEGRA MESHED DERMAL REGENERATION TEMPLATE
- PMA Number
- P900033
- Supplement Number
- S033
- Device Class
- FDA Class 3
- Product Code
- MDD
- Generic Name
- Device, dermal replacement
- Medical Specialty
- Unknown
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 7, 2014
- Date Received
- January 7, 2014
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A DESIGN CHANGE TO THE INTEGRA® DERMAL REGENERATIONTEMPLATE. THE DESIGN CHANGE WAS TO PRODUCE A MESHED VERSION OF THE INTEGRA® DERMAL REGENERATION TEMPLATE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INTEGRA® MESHED DERMAL REGENERATION TEMPLATE AND IS INDICATED FOR THE POST EXCISIONAL TREATMENT OF LIFE-THREATENING FULL-THICKNESS OR DEEP PARTIAL THERMAL INJURIES WHERE SUFFICIENT AUTOGRAFT IS NOT AVAILABLE AT THE TIME OF EXCISION OR NOT DESIRABLE DUE TO THE PHYSIOLOGICAL CONDITION OF THE PATIENT. IT IS ALSO INDICATED FOR THE REPAIR OF SCAR CONTRACTURES WHEN OTHER THERAPIES HAVE FAILED OR WHEN DONOR SITES FOR REPAIR ARE NOT SUFFICIENT OR DESIRABLE DUE TO THE PHYSIOLOGICAL CONDITION OF THE PATIENT.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MDD | Device, Dermal Replacement | FDA class 3 | Unknown |