FDA product code DSZ: Pacemaker Battery
DSZ is the FDA product code for pacemaker battery. It is a Class III device, regulated under 21 CFR 870.3610 and reviewed by the Cardiovascular panel. Devices under DSZ reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for DSZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Pacemaker Battery |
| Device class | Class III |
| Regulation | 21 CFR 870.3610 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | PMA |
| Implant | Yes |
Recalls for DSZ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-12-05.
Frequently asked questions
What is FDA product code DSZ?
DSZ is the FDA product code for pacemaker battery. It is a Class III device, regulated under 21 CFR 870.3610 and reviewed by the Cardiovascular panel.
What device class is DSZ?
Class III, regulation 21 CFR 870.3610. Typical premarket route: PMA.
Have DSZ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2012-12-05.
Next steps
- Run an FDA pathway report with predicate devices for product code DSZ
- Run a recall and safety report across every DSZ manufacturer
- Watch product code DSZ 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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