St. Jude Medical, Cardiac Rhythm Management Divisi: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “St. Jude Medical, Cardiac Rhythm Management Divisi” (first 2008, latest 2012), plus 2 PMA decisions, across 8 product codes in 1 review panel. Median 510(k) review time under this name: 100 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Abbott, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 101 |
| 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 4 | 4 |
| DRB | Stylet, Catheter | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| DTB | Permanent Pacemaker Electrode | 1 | 0 |
| DXY | Implantable Pacemaker Pulse-Generator | 1 | 0 |
| DYB | Introducer, Catheter | 1 | 1 |
| MXC | Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) | 1 | 1 |
Review panels
- Cardiovascular (12)
Most recent St. Jude Medical, Cardiac Rhythm Management Divisi 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122090 | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR | MXC | 2012-11-15 | 122 |
| K120296 | CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER | DQY | 2012-05-11 | 101 |
| K120298 | CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE | DQX | 2012-05-08 | 98 |
| K111943 | AGILLS PF DELIVERY SYSTEM | DYB | 2011-09-29 | 83 |
| K103250 | CPS DIRECT SL II SLITTABLE OUTER CATHETER | DQY | 2011-01-19 | 77 |
| K093858 | PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A | DSA | 2010-04-02 | 107 |
| K092075 | CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 | DQY | 2009-08-07 | 29 |
| K090613 | CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 | DQY | 2009-07-01 | 117 |
| K080924 | MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 | DRB | 2008-04-30 | 28 |
| K072864 | ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM | DRB | 2008-03-13 | 160 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P920011 | PMA | MAXIM PFS MODEL 033-301 | 1996-11-07 |
| P900070 | PMA | META DDDR PACING SYSTEM | 1992-01-30 |
Recalls
openFDA lists no recalls under a recalling firm named St. Jude Medical, Cardiac Rhythm Management Divisi.
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 St. Jude Medical, Cardiac Rhythm Management Divisi (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
Frequently asked questions
How many FDA 510(k) clearances are listed under St. Jude Medical, Cardiac Rhythm Management Divisi?
FDA lists 10 510(k) clearances under the applicant name “St. Jude Medical, Cardiac Rhythm Management Divisi” (first 2008, latest 2012), plus 2 PMA decisions, across 8 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 St. Jude Medical, Cardiac Rhythm Management Divisi?
The median time from FDA receipt to decision across 510(k)s cleared under the name St. Jude Medical, Cardiac Rhythm Management Divisi is 100 days.
Which FDA product codes appear under St. Jude Medical, Cardiac Rhythm Management Divisi?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 4); DRB (Stylet, Catheter, 2); DQX (Wire, Guide, Catheter, 1).
Next steps
- See all 10 St. Jude Medical, Cardiac Rhythm Management Divisi clearances with predicates and recalls
- Run predicate analysis for product code DQY, St. Jude Medical, Cardiac Rhythm Management Divisi'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.