PMA P900033S042
- Device
- INTEGRA(R) DERMAL REGENERATION TEMPLATE,INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE,OMNIGRAFT (TM) DERMAL REGENERATIO
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S042
- Product code
- MDD
- Decision date
- 2016-01-07
- Classification
- Device, Dermal Replacement
- Generic name
- Device, dermal replacement
- 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P900033S042B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- INTEGRA(R) DERMAL REGENERATION TEMPLATE,INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE,OMNIGRAFT (TM) DERMAL REGENERATIO
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S042
- Product code
- MDD
- Generic name
- Device, dermal replacement
- Decision date
- 2016-01-07
- Decision code
- APPR
- Date received
- 2015-01-29
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.