Card Tech Minutes 2015.03.18-20: Difference between revisions
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:Was the plan to support both Serial Number and/or FDA UDI? '''The serial number and model number from the manufacturer may be used until the UDI is the standard.''' | :Was the plan to support both Serial Number and/or FDA UDI? '''The serial number and model number from the manufacturer may be used until the UDI is the standard.''' | ||
:Will this be global profile or for use primarily in the US? '''This will be used world wide.''' | :Will this be global profile or for use primarily in the US? '''This will be used world wide.''' | ||
:Several descriptions of the measurements associated with the procedure and quantification included incremental results. Post | :Several descriptions of the measurements associated with the procedure and quantification included incremental results. Post deployment observations will be in the '''Findings''' part of the report. The goal is to keep the report flexible enough for them to document any eventuality. | ||
:Where do we post findings found in the various steps of the procedure? '''These intermediate 'guideposts' may not be as vital as the final results, unless there are other clinically useful trends that could be spotted.''''\ | |||
Revision as of 13:01, 26 May 2015
5/26/2015, Tuesday
- CRC TAVR Discussion
- Was the plan to support both Serial Number and/or FDA UDI? The serial number and model number from the manufacturer may be used until the UDI is the standard.
- Will this be global profile or for use primarily in the US? This will be used world wide.
- Several descriptions of the measurements associated with the procedure and quantification included incremental results. Post deployment observations will be in the Findings part of the report. The goal is to keep the report flexible enough for them to document any eventuality.
- Where do we post findings found in the various steps of the procedure? These intermediate 'guideposts' may not be as vital as the final results, unless there are other clinically useful trends that could be spotted.'\