| Device |
nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae repair or replacement |
| Regulation Description |
Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene. |
| Definition |
To repair or replace chordae tendinae. |
| Physical State |
Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in repair or replacement of chordae tendinae. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s). |
| Technical Method |
provides tension between the papilary muscles and valve leaflets to prevent valve leaflet prolapse by restoring natural function of the chordae tendinae. |
| Target Area |
Mitral and Tricuspid valve apparatus. |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | PAW |
|---|
| Premarket Review |
Circulatory Support, Structural and Vascular Devices
(DHT2B)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.3470
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
Yes
|
|---|
| Third Party Review |
Not Third Party Eligible |
