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Test Description
Implantation tests are performed to evaluate the local pathological effects on living tissue, at both the gross level and microscopic level, after implantation of samples of medical devices or bio-materials. The implant location is based on the clinical site of use. Implant duration’s are based on the need to evaluate the tissue response over multiple intervals and along with the sample’s inertness and absorptive characteristics
This implant study involves placement of a portion of a test article in the para-vertebral muscle. A negative control is also implanted. Following the listed time of implantation, sites are collected, slides prepared and a microscopic evaluation performed to determine the extent of a local tissue response.
Test Code | Variation |
---|---|
TI250-001 | with Sponsor Control - 1 Wk |
TI250-002 | with Sponsor Control - 2 Wk |
TI250-003 | with Sponsor Control - 3 Wk |
TI250-004 | with Sponsor Control - 4 Wk |
TI250-006 | with Sponsor Control - 6 Wk |
TI250-009 | with Sponsor Control - 9 Wk |
TI250-012 | with Sponsor Control - 12 Wk |
TI250-026 | with Sponsor Control - 26 Wk |
TI250-052 | with Sponsor Control - 52 Wk |
TI250-801 | 1 Wk |
TI250-802 | 2 Wk |
TI250-803 | 3 Wk |
TI250-804 | 4 Wk |
TI250-806 | 6 Wk |
TI250-809 | 9 Wk |
TI250-812 | 12 Wk |
TI250-826 | 26 Wk |
TI250-83R | 3 Subject, Variable Interval |
TI250-84R | 3 Subject, Variable Interval |
TI250-852 | 52 Wk |