FDA product code MPC: Atrial Defibrillator
MPC is the FDA product code for atrial defibrillator. It is a Class III device, regulated under 21 CFR 870.5300 and reviewed by the Cardiovascular panel. Devices under MPC reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs 12/26/96 (61 FR 50706 9/27/96)) Patients who are icd indicated and who have atrial tachyarrhythmias, or who are at risk of developing atrial tachyarrhythmias.
Classification
| Field | Value |
|---|---|
| Device name | Atrial Defibrillator |
| Device class | Class III |
| Regulation | 21 CFR 870.5300 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for MPC devices
openFDA lists no recalls for product code MPC.
Frequently asked questions
What is FDA product code MPC?
MPC is the FDA product code for atrial defibrillator. It is a Class III device, regulated under 21 CFR 870.5300 and reviewed by the Cardiovascular panel.
What device class is MPC?
Class III, regulation 21 CFR 870.5300. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MPC
- Run a recall and safety report across every MPC manufacturer
- Watch product code MPC 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.