FDA product code LPA: System, Esophageal Pacing
LPA is the FDA product code for system, esophageal pacing. It is a Class III device, reviewed by the Cardiovascular panel. Devices under LPA reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 5 recalls for LPA devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Esophageal Pacing |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LPA devices
5 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-06-24.
| Year | Recalls |
|---|---|
| 2019 | 2 |
Frequently asked questions
What is FDA product code LPA?
LPA is the FDA product code for system, esophageal pacing. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is LPA?
Class III. Typical premarket route: PMA.
Have LPA devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2019-06-24.
Next steps
- Run an FDA pathway report with predicate devices for product code LPA
- Run a recall and safety report across every LPA manufacturer
- Watch product code LPA 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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