FDA product code record
Product code OJX
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA product classification. Device class 3. Review panel CV.
Classification
Each row is one field of the openFDA record. The grey name is the field’s name in openFDA’s documentation.
| Field | Value | Field name |
|---|---|---|
| Product code | OJX | product_code |
| Device name | Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode | device_name |
| Device class | 3 | device_class |
| Review panel | CV | review_panel |
| Regulation number | empty | regulation_number |
| Medical specialty | Unknown | medical_specialty |
Source: FDA openFDA, device/classification, product code OJX, as held in ArrHub’s controlled vocabulary with its citation. Public domain (CC0).
PMA records with this code
Every verified record ArrHub holds under the code, newest first.
| Decision | Applicant | Device | Record |
|---|---|---|---|
| 2026-06-24 | Medtronic, Inc. | Attain Ability Lead (4196, 4296), Attain Ability Lead (4396), Attain Performa Lead (4298, 4398, 4598), Attain Stability (truncated in the FDA record) | P080006/S193 FDA |
| 2026-04-15 | Medtronic, Inc. | Attain Ability Lead, Attain Performa Lead (4398,4598), Attain Performa Lead (4298), Attain Stability Quad MRI Lead | P080006/S192 FDA |
| 2026-02-10 | Medtronic, Inc. | Attain StarFix Lead | P060039/S119 FDA |
| 2009-04-07 | Medtronic, Inc. | MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD | P080006 FDA |
| 2008-06-13 | Medtronic, Inc. | ATTAIN STARFIX MODEL 4195 LEAD | P060039 FDA |
510(k) clearances with this code
Every verified record ArrHub holds under the code, newest first.
None in the verified view.
ArrHub
What ArrHub adds to the record. Everything above this line is the agency’s; everything here is ArrHub’s, dated and attributed.
ArrHub vocabulary
Electrophysiology
OJX is one of the 56 product codes in ArrHub’s electrophysiology vocabulary, each held with its FDA classification record as its citation. Vocabulary entry verified 20 September 2026.
Raw record
The stored record exactly as ArrHub holds it, for anyone who wants to check the page against it.
Show the raw record (JSON)device/classification.json?search=product_code:OJX
{
"id": "fda_product_code:OJX",
"vocabulary": "fda_product_code",
"term": "OJX",
"definition": "Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode",
"attrs": {
"device_class": "3",
"review_panel": "CV",
"medical_specialty": "Unknown",
"regulation_number": ""
},
"jurisdiction": "US",
"authority": "FDA",
"ep_relevant": true,
"source_url": "https://api.fda.gov/device/classification.json?search=product_code:OJX",
"verified_by": "Bruno Deslauriers",
"verified_at": "2026-09-20T01:22:27.524165+00:00",
"notes": "Fetched from https://open.fda.gov/apis/device/classification/",
"created_at": "2026-09-20T01:19:17.515628+00:00",
"updated_at": "2026-09-20T01:19:03.212+00:00"
}The readable page is rendered from the record held in ArrHub’s verified view; the agency record at api.fda.gov governs where they differ.
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