Existing clinical data (a) Summary of relevant previous clinical experience with the ...

Device description and product specification, including variants and accessories 2.1 ...

2.0 Device description and product specification, including variants and accessories ...

2.0 Device description and product specification, including variants and accessories ...

Actions taken in reporting interval for safety reasons: This section of PSUR shall in ...

Overall synopsis of the clinical investigation A summary or overview of the clinical ...

Post Marketing Surveillance: (i) Subsequent to approval of an Investigational medical ...

Investigational medical device and methods 6.1 Investigational medical device descrip ...