PMA supplement
P100029 S035: Trifecta Valve / Trifecta Valve with Glide Technology (Trifecta GT)
FDA PMA supplement · Special (Immediate Track) · ABBOTT MEDICAL
Key facts
| Original PMA | P100029 |
|---|---|
| Supplement number | S035 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Trifecta Valve / Trifecta Valve with Glide Technology (Trifecta GT ) |
| Generic name | Heart-valve, non-allograft tissue |
| Applicant | ABBOTT MEDICAL |
| Product code | LWR |
| Received date | Aug 13, 2018 |
| Decision date | Sep 10, 2018 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: