Search Results

The CP Medical Polydioxanone Synthetic Absorbable Seeding Spacers are single-use, absorbable seeds comprised of spacer material used to provide a predetermined space between radionuclide seeds for brachytherapy procedures. CP Medical's synthetic absorbable seeding spacers, made of polydioxanone material, are indicated for use in brachytherapy, soft tissue, or organ tissue but should not be used during cardiovascular or neurological procedures.

The CP Medical Polydioxanone Synthetic Absorbable Seeding Spacer consists of absorbable spacer material, which is cut into a small cylindrical seed spacer utilized to provide space between the radionuclide seeds as they are implanted into the body.

The provided text describes a 510(k) premarket notification for a medical device (Polydioxanone Synthetic Absorbable Seeding Spacers) and its substantial equivalence determination. It does not contain information about acceptance criteria, device performance results, sample sizes, expert qualifications, adjudication methods, or specific study details relating to proving the device meets acceptance criteria.

The document is a regulatory approval notice, not a study report. Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device