Search Results

The ProLong-EX permits placement of catheters next to nerves and nerve plexus for continuous nerve block anesthesia or analgesia techniques. It is infileated for use up to 72 hours, and is for adult art paid.atric use.

Not Found

This is a 510(k) clearance letter for the ProLong-EX Continuous Nerve Block Set. It states that the device is substantially equivalent to legally marketed predicate devices. This type of regulatory submission typically does not include detailed performance studies with acceptance criteria, sample sizes, expert involvement, or training set information as would be found in a Premarket Approval (PMA) application or a de novo submission.

Therefore, based on the provided document, I cannot extract the information requested regarding acceptance criteria and the study proving the device meets them. The document primarily focuses on the regulatory approval process through substantial equivalence.

Ask a specific question about this device