PCX — Artificial Chordae Tendinae Delivery System Class N
FDA product code PCX covers "Artificial Chordae Tendinae Delivery System", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PCX
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Unknown
- Implant
- No
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.