FDA product code DTB: Permanent Pacemaker Electrode
DTB is the FDA product code for permanent pacemaker electrode. It is a Class III device, regulated under 21 CFR 870.3680 and reviewed by the Cardiovascular panel. FDA has cleared 487 510(k) submissions under DTB, from 53 different applicants. The average 510(k) review took 119 days (median 79). 15 PMA applications cite this product code. FDA has posted 8 recalls for DTB devices.
Classification
| Field | Value |
|---|---|
| Device name | Permanent Pacemaker Electrode |
| Device class | Class III |
| Regulation | 21 CFR 870.3680 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | PMA |
| Implant | Yes |
Compare with all 510(k) review times · Search every DTB clearance
Top DTB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intermedics, Inc. | 105 | 1996-12-16 |
| Medtronic Vascular | 69 | 2003-05-22 |
| Telectronics, Inc. | 35 | 1989-02-02 |
| Pacesetter Systems | 33 | 1991-08-28 |
| Daig Corp. | 28 | 1990-01-18 |
48 more applicants have DTB clearances. See the full list in Caduvo.
Most recent DTB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K061212 | Biotronik, Inc. | BIOTRONIK ENDOCARDIAL PACING LEADS | 2006-07-10 | 70 |
| K041809 | Oscor, Inc. | PERMANENT PACING LEAD, MODEL PY2 | 2004-08-06 | 31 |
| K040569 | Oscor, Inc. | PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU | 2004-04-07 | 34 |
| K031274 | Medtronic Vascular | MODEL 5071 MYOCARDIAL PACING LEAD | 2003-05-22 | 30 |
| K031210 | Metronic, Inc. | MODEL 4951M MYOCARDIAL UNIPOLAR LEAD | 2003-05-16 | 29 |
Recalls for DTB devices
8 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-09-15.
Frequently asked questions
What is FDA product code DTB?
DTB is the FDA product code for permanent pacemaker electrode. It is a Class III device, regulated under 21 CFR 870.3680 and reviewed by the Cardiovascular panel.
What device class is DTB?
Class III, regulation 21 CFR 870.3680. Typical premarket route: PMA.
How long does a 510(k) take for product code DTB?
Across 487 cleared submissions the average was 119 days from receipt to decision (median 79).
Which companies have the most DTB clearances?
Intermedics, Inc. (105); Medtronic Vascular (69); Telectronics, Inc. (35); Pacesetter Systems (33); Daig Corp. (28).
Have DTB devices been recalled?
Yes: 8 product recalls across 6 recall events; the most recent began 2015-09-15.
Next steps
- Run an FDA pathway report with predicate devices for product code DTB
- Run a recall and safety report across every DTB manufacturer
- Watch product code DTB 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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