Product code PCX
- Device name
- Artificial Chordae Tendinae Delivery System
- Medical specialty
- Unknown
- Device class
- N
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Deploys ePTFE suture, labeled for use as artificial chordae tendinae, while the heart is beating as an alternative to the conventional surgical approach for this type of mitral valve repair.
- Source
- FDA openFDA device classification dataset