FDA product code SEG: Leadless Cardiac Resynchronization Therapy (Crt)
SEG is the FDA product code for leadless cardiac resynchronization therapy (crt). It is a Class III device, reviewed by the Cardiovascular panel. Devices under SEG reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Leadless Cardiac Resynchronization Therapy (CRT) is intended to deliver CRT using a leadless left ventricular implant
Classification
| Field | Value |
|---|---|
| Device name | Leadless Cardiac Resynchronization Therapy (Crt) |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for SEG devices
openFDA lists no recalls for product code SEG.
Frequently asked questions
What is FDA product code SEG?
SEG is the FDA product code for leadless cardiac resynchronization therapy (crt). It is a Class III device, reviewed by the Cardiovascular panel.
What device class is SEG?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SEG
- Run a recall and safety report across every SEG manufacturer
- Watch product code SEG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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