Pantheon Vision Announces Two Successful Pre-Submission Meetings With the FDA
Pantheon Vision, a pre-clinical stage medical device company developing bioengineered corneal implants to eliminate corneal blindness, announced today the completion of two successful and productive Pre-Submission meetings with the U.S. Food and Drug Administration (FDA).
- Pantheon Vision, a pre-clinical stage medical device company developing bioengineered corneal implants to eliminate corneal blindness, announced today the completion of two successful and productive Pre-Submission meetings with the U.S. Food and Drug Administration (FDA).
- Pantheon Vision requested these early interactions with the FDA review team to obtain agency guidance on preclinical and clinical work supporting a Premarket Approval (PMA) submission.
- “We are thrilled with the results of the Pre-Submission meetings with the FDA as this is a pivotal step towards a PMA acceptance.
- This interactive meeting was an opportunity for us to gather feedback before our planned premarket submission,” said John Sheets, President and CEO, Pantheon Vision.