- Device
- INTEGRA DERMAL REGENERATION TEMPLATE, INTEGRA MESHED DERMAL REGENERATION TEMPLATE
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S033
- Product code
- MDD
- Generic name
- Device, dermal replacement
- Decision date
- 2014-04-07
- Decision code
- APPR
- Date received
- 2014-01-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.