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jjljr

09/11/19 8:42 AM

#95773 RE: West Coast Snapper #95771

So 16 weeks in "Titan" time

RockoTaco

09/11/19 8:42 AM

#95774 RE: West Coast Snapper #95771

That has to do with Sterilization and not an "engineering issue".

From the presentation:

Fourth Quarter:
• Implement software enhancements, improvements to instruments and sterile interface
• Obtain ISO 13485 Certification
• Submit IDE application to FDA
• Receive IDE approval from FDA