Product code PAW

Device name

Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.3470

Review panel

CV

Implant

Y

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

To repair or replace chordae tendinae.

Source

FDA openFDA device classification dataset