Telectronics Pacing Systems, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Telectronics Pacing Systems, Inc.” (first 1989, latest 1996), plus 2 PMA decisions, across 7 product codes in 1 review panel. Median 510(k) review time under this name: 126 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | 10 | 10 |
| DTD | Pacemaker Lead Adaptor | 5 | 5 |
| DXY | Implantable Pacemaker Pulse-Generator | 3 | 3 |
| DYB | Introducer, Catheter | 1 | 1 |
| KFJ | Materials, Repair Or Replacement, Pacemaker | 1 | 1 |
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | 1 | 0 |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | 1 | 0 |
Review panels
- Cardiovascular (22)
Most recent Telectronics Pacing Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961118 | MAXIM PF MODELS 033-581/033-590 | DTB | 1996-07-15 | 117 |
| K943657 | STERILIZATION | DTB | 1996-06-24 | 698 |
| K934899 | BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM | DTD | 1994-05-12 | 210 |
| K926340 | NEW LEAD INTRODUCER KITS, VARIOUS MODELS | DYB | 1993-05-27 | 161 |
| K914489 | NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING | DTB | 1992-08-17 | 314 |
| K913919 | UNIVERSAL TERMINAL CAP, 3.2MM | KFJ | 1991-12-31 | 119 |
| K912773 | UNIPOLAR UPSIZING ADAPTOR | DTD | 1991-10-23 | 121 |
| K911273 | 100 CM PERMANENT PACING LEAD MODELS | DTB | 1991-08-28 | 159 |
| K910112 | BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR | DTD | 1991-02-25 | 46 |
| K903186 | OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE | DXY | 1991-01-18 | 183 |
10 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P940024 | PMA | GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB. | 1997-07-03 |
| P830007 | PMA | GEMINI(R) THETA MODEL 415A CARDIAC PACER | 1983-11-10 |
Recalls
openFDA lists no recalls under a recalling firm named Telectronics Pacing Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Telectronics Pacing Systems, Inc. (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via LWP)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Telectronics, Inc. (107 510(k)s)
- Telectronics and Cordis Pacing Systems (3 510(k)s)
- Telectronics and Control Pacing Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Telectronics Pacing Systems, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Telectronics Pacing Systems, Inc.” (first 1989, latest 1996), plus 2 PMA decisions, across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Telectronics Pacing Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Telectronics Pacing Systems, Inc. is 126 days.
Which FDA product codes appear under Telectronics Pacing Systems, Inc.?
The most frequent FDA product codes under this applicant name are DTB (Permanent Pacemaker Electrode, 10); DTD (Pacemaker Lead Adaptor, 5); DXY (Implantable Pacemaker Pulse-Generator, 3).
Next steps
- See all 20 Telectronics Pacing Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTB, Telectronics Pacing Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.