|
Device | INTEGRA(R) DERMAL REGENERATION TEMPLATE,INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE,OMNIGRAFT (TM) DERMAL REGENERATIO |
Generic Name | Device, dermal replacement |
Applicant | Integra LifeSciences Corp. 105 MORGAN LN. PLAINSBORO, NJ 08536 |
PMA Number | P900033 |
Supplement Number | S042 |
Date Received | 01/29/2015 |
Decision Date | 01/07/2016 |
Product Codes |
MDD MGR |
Docket Number | 16M-0121 |
Notice Date | 01/11/2016 |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT01060670
|
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 OMNIGRAFT DERMAL REGENERATION MATRIX (A.K.A. OMNIGRAFT) AND INTEGRA DERMAL REGENERATION TEMPLATE. INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX IS INDICATED FOR USE IN THE TREATMENT OF PARTIAL AND FULL-THICKNESS NEUROPATHIC DIABETIC FOOT ULCERS THAT ARE GREATER THAN SIX WEEKS IN DURATION, WITH NO CAPSULE, TENDON OR BONE EXPOSED, WHEN USED IN CONJUNCTION WITH STANDARD DIABETIC ULCER CARE AND INTEGRA DERMAL REGENERATION TEMPLATE 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; 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; AND TREATMENT OF PARTIAL AND FULL-THICKNESS NEUROPATHIC DIABETIC FOOT ULCERS THAT ARE GREATER THAN SIX WEEKS IN DURATION WITH NO CAPSULE, TENDON OR BONE EXPOSED, WHEN USED IN CONJUNCTION WITH STANDARD DIABETIC ULCER CARE. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |