FDA product code DTA: Tester, Pacemaker Electrode Function
DTA is the FDA product code for tester, pacemaker electrode function. It is a Class II device, regulated under 21 CFR 870.3720 and reviewed by the Cardiovascular panel. FDA has cleared 10 510(k) submissions under DTA, from 8 different applicants. The average 510(k) review took 95 days (median 93). 1 PMA application cites this product code. FDA has posted 2 recalls for DTA devices.
Classification
| Field | Value |
|---|---|
| Device name | Tester, Pacemaker Electrode Function |
| Device class | Class II |
| Regulation | 21 CFR 870.3720 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DTA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 123 |
Compare with all 510(k) review times · Search every DTA clearance
Top DTA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biotronik, Inc. | 3 | 2007-12-20 |
| Medtronic, Inc. | 1 | 2017-02-28 |
| St Jude Medical, Crmd | 1 | 2010-12-21 |
| Remington Medical, Inc. | 1 | 2005-05-19 |
| Ep Medical, Inc. | 1 | 1993-10-21 |
3 more applicants have DTA clearances. See the full list in Caduvo.
Most recent DTA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K163008 | Medtronic, Inc. | CareLink SmartSync Device Manager - Pacing System Analyzer | 2017-02-28 | 123 |
| K101982 | St Jude Medical, Crmd | MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 | 2010-12-21 | 160 |
| K073230 | Biotronik, Inc. | MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS | 2007-12-20 | 35 |
| K050884 | Remington Medical, Inc. | ADAPTER CABLE | 2005-05-19 | 42 |
| K033613 | Biotronik, Inc. | MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER | 2003-12-08 | 21 |
Recalls for DTA devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-08-31.
Frequently asked questions
What is FDA product code DTA?
DTA is the FDA product code for tester, pacemaker electrode function. It is a Class II device, regulated under 21 CFR 870.3720 and reviewed by the Cardiovascular panel.
What device class is DTA?
Class II, regulation 21 CFR 870.3720. Typical premarket route: 510(k).
How long does a 510(k) take for product code DTA?
Across 10 cleared submissions the average was 95 days from receipt to decision (median 93).
Which companies have the most DTA clearances?
Biotronik, Inc. (3); Medtronic, Inc. (1); St Jude Medical, Crmd (1); Remington Medical, Inc. (1); Ep Medical, Inc. (1).
Have DTA devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2005-08-31.
Next steps
- Run an FDA pathway report with predicate devices for product code DTA
- Run a recall and safety report across every DTA manufacturer
- Watch product code DTA 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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