Product code
PAW: Nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae repair or replacement
FDA product code · Class II · Cardiovascular
Key facts
| Product code | PAW |
|---|---|
| Device | Nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae repair or replacement |
| Device class | Class II |
| Regulation number | 878.5035 |
| Review panel | Cardiovascular |
| Medical specialty | General & Plastic Surgery |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | Yes |
| Definition | To repair or replace chordae tendinae. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database