INFORMATION TO BE SUBMITTED ALONG WITH THE APPLICATION 1. Design Analysis data including, (whichever applicable), — (a) design input and design output documents; (b) mechanical and electrical tests; (c) reliability tests; (d) validation of software relating to the function of the device; (e) any performance tests; (f) ex vivo tests. 2. The agreement between the Sponsor and Principal and coordinating investigator(s). 3. Appropriate insurance certificate, if any. 4. Forms for reporting any adverse event and serious adverse event. 5. Report of bio-compatibility tests along with rationale for selecting these tests including a summary report and conclusion of the study. 6. Results of the risk analysis. 7. Animal Performance study data 8. Clinical Investigational Plan, Investigator's Brochure as per Table 4, Case Report Form as per Table 6, Informed Consent Form as per Table 8, investigator undertaking and Ethics Committee clearance. 9. Pilot and Pivotal Clinical Investigation data including that, if any, carried out in other countries. 10. Regulatory status and Restriction on use in other countries, if any, where marketed or approved.