DDD Pulse Generator 674
by Pacesetter Systems PMA
Active
PMA P840014
Overview
DDD Pulse Generator 674 is an implantable pulse generator, pacemaker (non-CRT) as defined by its generic name and FDA classification. It is designed to deliver electrical impulses to regulate heart rhythm in patients requiring cardiac pacing.
The device is supplied as an implantable system intended for surgical placement. It is a reusable implantable device subject to FDA Premarket Approval (PMA) under number P840014, with manufacturing and distribution governed by Pacesetter Systems in Sylmar, California.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP840014 | Date31 Jul 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Generic Name
- Implantable pulse generator, pacemaker (non-CRT)
- PMA Number
- FDA Product Code
- LWP
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Other devices from Pacesetter Systems
Questions
What type of device is the DDD Pulse Generator 674?
The DDD Pulse Generator 674 is classified as an implantable pulse generator, pacemaker (non-CRT), based on its generic name and FDA device classification. This indicates it is a cardiac pacing device that does not provide cardiac resynchronization therapy.
Who manufactures the DDD Pulse Generator 674 and where are they located?
The DDD Pulse Generator 674 is manufactured by Pacesetter Systems, located at 12884 Bradley Ave., Sylmar, CA 91342, as stated in the manufacturer and address fields of the device data.
What regulatory authorization does the DDD Pulse Generator 674 have?
The DDD Pulse Generator 674 has FDA Premarket Approval (PMA), as indicated by the AUTHORIZATIONS field listing FDA_PMA and the PMA number P840014 in the specifications. This approval was granted on July 31, 1986.