|
Device | INTEGRA DERMAL REGENERATION TEMPLATE |
Generic Name | Device, dermal replacement |
Applicant | Integra LifeSciences Corp. 105 MORGAN LN. PLAINSBORO, NJ 08536 |
PMA Number | P900033 |
Supplement Number | S008 |
Date Received | 10/26/2001 |
Decision Date | 04/19/2002 |
Product Codes |
MDD MGR |
Docket Number | 02M-0216 |
Notice Date | 05/13/2002 |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE INTEGRA DERMAL REGENERATION TEMPLATE. THIS DEVICE IS INDICATED FOR "THE POSTEXCISIONAL TREATMENT OF LIFE-THREATENING FULL-THICKNESS OR DEEP PARTIAL-THICKNESS THERMAL INJURIES WHERE SUFFICIENT AUTOGRAFT IS NOT AVAILABLE AT THE TIME OF EXCISION OR NOT DESIRABLE DUE TO THE PHYSIOLOGICAL CONDITION OF THE PATIENT. INTEGRA DERMAL REGENERATION TEMPLATE 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." |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |