FDA product code SJL: Heart-Valve, Polymeric
SJL is the FDA product code for heart-valve, polymeric. It is a Class III device, reviewed by the Cardiovascular panel. Devices under SJL reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
This device is a permanent implant intended to replace a heart valve.
Classification
| Field | Value |
|---|---|
| Device name | Heart-Valve, Polymeric |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for SJL devices
FDA recall records list no recalls for product code SJL.
Frequently asked questions
What is FDA product code SJL?
SJL is the FDA product code for heart-valve, polymeric. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is SJL?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SJL
- Run a recall and safety report across every SJL manufacturer
- Watch product code SJL for new clearances and recalls
Compiled by Caduvo from public U.S. FDA records. Applicant names are shown as FDA records them. Review days run from FDA receipt to decision. Not reviewed or endorsed by FDA. Not regulatory advice. Report an error. Data and corrections policy.
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