Pacesetter Systems - FDA 510(k) Cleared Devices

Pacesetter Systems was a biotechnology company founded by Alfred E. Mann in 1965, headquartered in McHenry, US. The company pioneered implantable medical devices, including the first commercial rechargeable implantable pacemaker and early telemetry-enabled systems.

Pacesetter Systems received 96 FDA 510(k) clearances from 96 total submissions between 1976 and 1991. The company's regulatory focus centered on Cardiovascular devices, which represented 91% of all submissions. This historical record reflects the company's core expertise in pacemaker technology, leads, adapters, and pulse generators.

The company was acquired by Siemens and subsequently by St. Jude Medical in 1994. Pacesetter Systems is now inactive, with no FDA 510(k) clearances recorded after 1991. This profile serves as a historical regulatory record for the company's contributions to implantable cardiac device development.

Explore the complete list of device names, product codes, and clearance dates in the database to review Pacesetter Systems' full regulatory history.