Pacesetter Systems: FDA filings under this applicant name
FDA lists 96 510(k) clearances under the applicant name “Pacesetter Systems” (first 1976, latest 1991), plus 2 PMA decisions, across 13 product codes in 3 review panels. Median 510(k) review time under this name: 61 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 | 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 | 33 | 33 |
| DXY | Implantable Pacemaker Pulse-Generator | 28 | 28 |
| DTD | Pacemaker Lead Adaptor | 20 | 20 |
| FRN | Pump, Infusion | 7 | 7 |
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | 2 | 0 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 1 | 1 |
| DTG | Magnet, Test, Pacemaker | 1 | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent Pacesetter Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910924 | ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE | DTB | 1991-08-28 | 176 |
| K902147 | ENDOCARDIAL SCREW-IN LEAD MODEL 1028T | DTB | 1990-07-17 | 63 |
| K900512 | SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS | DTD | 1990-06-25 | 143 |
| K900550 | FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T | DTB | 1990-04-20 | 73 |
| K895447 | ENDOCARDIAL SCREW-IN LEAD MODEL 1020T | DTB | 1989-12-20 | 103 |
| K891905 | CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE | DTB | 1989-06-05 | 70 |
| K885267 | VS-1 MODEL NUMBER 251K PULSE GENERATOR | DXY | 1989-03-28 | 96 |
| K890547 | SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS | DTB | 1989-03-22 | 47 |
| K884733 | AFP MODEL 262T PULSE GENERATOR | DXY | 1989-02-10 | 92 |
| K883087 | PROLOG MP 658M PULSE GENERATOR | DXY | 1988-09-14 | 55 |
86 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P840014 | PMA | DDD PULSE GENERATOR 674 | 1986-07-31 |
| P820023 | PMA | PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P | 1983-02-04 |
Recalls
openFDA lists no recalls under a recalling firm named Pacesetter Systems.
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 Pacesetter Systems (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via LWP)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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.
- Pacesetter, Inc. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pacesetter Systems?
FDA lists 96 510(k) clearances under the applicant name “Pacesetter Systems” (first 1976, latest 1991), plus 2 PMA decisions, across 13 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pacesetter Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pacesetter Systems is 61 days.
Which FDA product codes appear under Pacesetter Systems?
The most frequent FDA product codes under this applicant name are DTB (Permanent Pacemaker Electrode, 33); DXY (Implantable Pacemaker Pulse-Generator, 28); DTD (Pacemaker Lead Adaptor, 20).
Next steps
- See all 96 Pacesetter Systems clearances with predicates and recalls
- Run predicate analysis for product code DTB, Pacesetter Systems'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.