FDA product code OSR: Pacemaker/Icd/Crt Non-Implanted Components
OSR is the FDA product code for pacemaker/icd/crt non-implanted components. It is a Class III device, reviewed by the Cardiovascular panel. Devices under OSR reach the market by PMA; FDA lists no cleared 510(k)s for it. 10 PMA applications cite this product code. FDA has posted 15 recalls for OSR devices, 2 initiated in the last five years.
Definition
Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider.
Classification
| Field | Value |
|---|---|
| Device name | Pacemaker/Icd/Crt Non-Implanted Components |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for OSR devices
15 product recalls in 10 recall events; 2 initiated in the last five years and 10 still open. Most recent: 2022-03-10.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 3 |
| 2019 | 6 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code OSR?
OSR is the FDA product code for pacemaker/icd/crt non-implanted components. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is OSR?
Class III. Typical premarket route: PMA.
Have OSR devices been recalled?
Yes: 15 product recalls across 10 recall events; the most recent began 2022-03-10.
Next steps
- Run an FDA pathway report with predicate devices for product code OSR
- Run a recall and safety report across every OSR manufacturer
- Watch product code OSR 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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