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FDA product code · Cardiovascular

DTBPermanent Pacemaker Electrode

Product code DTB covers Permanent Pacemaker Electrode, a Class III device regulated under 21 CFR 870.3680. FDA has cleared 487 devices in this code. Median review time across the 487 most recent decisions is 79 days. openFDA lists 8 recall records against this code.

Updated · ingest status · JSON

Class
Class III
Regulation
21 CFR 870.3680
Review panel
Cardiovascular
Clearances
487

What is happening in DTB right now?

DTB (Permanent Pacemaker Electrode): nothing changed in the six FDA sources we watch.

Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.

How many devices has FDA cleared in DTB?

FDA has cleared 487 devices under product code DTB since the 510(k) programme began in 1976.

Source: openFDA device/510k · retrieved

Most recent 510(k) clearances in DTB, newest first.
510(k)DeviceApplicantDecision
K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.
K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.
K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.
K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic Vascular
K031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.
K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, Inc.
K024053PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJBOscor, Inc.
K023803MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESSBiotronik, Inc.
K023099AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBPBiotronik, Inc.
K021217AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBPBiotronik, Inc.

How long does FDA review take for DTB?

The median FDA review time for DTB is 79 days, measured across the 487 most recent decisions with both a received date and a decision date.

Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Are there recalls in DTB?

openFDA lists 8 recall records against product code DTB. A recall record covers one firm's corrective action and may span many device lots.

  • Z-0022-2016TerminatedMedtronic Inc. Cardiac Rhythm Disease Management

    Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of their implanted leads have been FDA approved as MR Conditional.

  • Z-0287-2011TerminatedGreatbatch Medical

    The Myopore Bipolar Epicardial Leads packaging is labeled as unipolar leads. The lead body itself is correctly labeled as bipolar. This could result in a bipolar lead being implanted with a pulse generator operating in unipolar mode.

  • Z-1200-2010TerminatedMedtronic Inc. Cardiac Rhythm Disease Managment

    Medtronic has identified a packaging issue for a subset of Epicardial Leads Model 5071. They determined that specific package seals could be compromised. Medtronic is not aware of any patient injury due to this packaging issue and their evaluation indicated the risk of patient injury is remote. However, a compromised package seal could potentially affect product sterility.

  • Z-0580-2010TerminatedGreatbatch Medical

    The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the performance characteristics are not available.

  • Z-0581-2010TerminatedGreatbatch Medical

    The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the performance characteristics are not available.

Showing the 5 most recently initiated of 8. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.

Source: openFDA device/recall · retrieved

How many adverse events are reported for DTB?

MAUDE holds 83,720 adverse-event reports naming product code DTB, 16,370 of them received in the last 12 months.

MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.

Source: openFDA device/event · retrieved

Is adverse-event reporting in DTB unusual?

One month sits above DTB's own expected range: 1 May 2025.

Monthly adverse-event reports naming DTB, against the expected range computed from this code's own history. Shaded band is the expected range; a bar above it is the month flagged. Retrieved 11 August 2026.
Reports received per month for DTB, with the expected range and whether the month fell outside it.
MonthReportsExpectedVerdict
2,060Insufficient historyNo expected range — too little history
1,953Insufficient historyNo expected range — too little history
2,146Insufficient historyNo expected range — too little history
1,943Insufficient historyNo expected range — too little history
2,469Insufficient historyNo expected range — too little history
2,296Insufficient historyNo expected range — too little history
2,357Insufficient historyNo expected range — too little history
7,766Insufficient historyNo expected range — too little history
2,310Insufficient historyNo expected range — too little history
2,254Insufficient historyNo expected range — too little history
2,117Insufficient historyNo expected range — too little history
2,221Insufficient historyNo expected range — too little history
2,417Insufficient historyNo expected range — too little history
2,087Insufficient historyNo expected range — too little history
1,805Insufficient historyNo expected range — too little history
2,260Insufficient historyNo expected range — too little history
2,171Insufficient historyNo expected range — too little history
1,949Insufficient historyNo expected range — too little history
2,301Insufficient historyNo expected range — too little history
2,172Insufficient historyNo expected range — too little history
1,935Insufficient historyNo expected range — too little history
1,8591,503–2,305Within expected (1,503–2,305)
1,8741,298–1,992Within expected (1,298–1,992)
1,7831,525–2,315Within expected (1,525–2,315)
2,1501,558–2,332Within expected (1,558–2,332)
2,3491,639–2,112Above expected (1,639–2,112)
2,1291,695–2,486Within expected (1,695–2,486)
2,3642,670–3,944Below expected (2,670–3,944)
1,9431,708–2,862Within expected (1,708–2,862)
2,5511,651–2,937Within expected (1,651–2,937)
2,2871,722–2,995Within expected (1,722–2,995)
1,9121,531–2,683Within expected (1,531–2,683)
1,8181,610–2,920Within expected (1,610–2,920)
2,1651,639–3,284Within expected (1,639–3,284)
1,9021,270–2,754Within expected (1,270–2,754)
2,2281,353–2,974Within expected (1,353–2,974)

21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in DTB.

What are the predicate devices in DTB?

FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.

A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.

Who files 510(k)s in DTB?

Across the 487 most recent decisions, these applicants filed most often in DTB.

Most frequent applicants in DTB among recent decisions.
ApplicantRecent clearances
Intermedics, Inc.105
Medtronic Vascular69
Telectronics, Inc.35
Pacesetter Systems33
Daig Corp.28

Applicant names above are exactly as FDA published them, so one company can appear under several spellings.

Source: openFDA device/510k · retrieved

Watch DTB

Get an email the morning anything changes in DTB — a new clearance, a recall, or an adverse-event spike above this code's own baseline.

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.