American Pacemaker Corp.
United StatesFDA applicant, unverified
- Devices
- 14
What American Pacemaker Corp. makes
American Pacemaker Corp. manufactures implantable and external cardiac pacing leads, including unipolar, bipolar, and demand-sensing designs such as the APC 3264, 3262, and 3266 models, as well as flange-equipped leads for pacemaker systems. Their portfolio also includes external pulse generators like the EV4542 and specialized pacing leads for unifocal and bifocal applications, such as the 8200 series and UNIFOCAL VP models (7501, 7502).
These devices are classified under FDA regulations as Class II (general controls with performance standards) and Class III (premarket approval required), with most submissions recorded via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Search and filter all 14 devicesFrequently asked questions
How many devices does American Pacemaker Corp. have in the registry?
The registry currently lists 14 devices for American Pacemaker Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Pacemaker Corp.'s devices?
Among its 14 most recently registered devices, American Pacemaker Corp. has devices listed in FDA 510(k) (14 devices).
What risk classes do American Pacemaker Corp.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for American Pacemaker Corp.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from American Pacemaker Corp. in the registry?
The most recently registered devices listed for American Pacemaker Corp. include APC IMPLANTABEL PACING LEAD, MODEL 3264, APC IMPLANTABLE PACING LEAD, TINED #3262, UNIFOCAL 1 UNIPOLAR DEMAND R WAVE and APC IMPLANTABLE PACING LEAD-FLANGE #3260.