Prolog MP 658M Pulse Generator
by Pacesetter Systems 510(k)
Active
510(k) K883087
Overview
The Prolog MP 658M Pulse Generator is an implantable pacemaker pulse-generator, designed to deliver electrical impulses to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders. It is classified as a Class III medical device under FDA regulations, requiring a Premarket Approval (PMA) or 510(k) clearance for commercialisation.
This device is intended for surgical implantation and is supplied sterile for single-use. It operates within MRI-safe parameters as defined by the manufacturer’s specifications, though specific MRI compatibility should be verified pre-procedure. The device is authorised under FDA 510(k) clearance (K883087) and adheres to regulatory requirements outlined in 21 CFR 870.3610 for implantable pacemaker pulse-generators. Storage and handling follow sterile medical device protocols to ensure functionality and patient safety.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883087 | Date14 Sep 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DXY
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3610
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Pacesetter Systems
Questions
What is the primary purpose of the PROLOG MP 658M Pulse Generator and what types of patients would benefit from it?
The PROLOG MP 658M Pulse Generator is designed to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders by delivering electrical impulses to the heart. It is intended for surgical implantation and is specifically engineered for patients who require pacing support due to slow heart rates or abnormal electrical signaling in the heart.
Is the PROLOG MP 658M Pulse Generator intended for single-use or can it be reused after sterilization?
The PROLOG MP 658M Pulse Generator is supplied sterile for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and device integrity, potentially affecting patient safety and device performance.
How should the PROLOG MP 658M Pulse Generator be stored to maintain its functionality and sterility?
The device must be stored following sterile medical device protocols to preserve its functionality and ensure patient safety. Since it is supplied sterile for single-use, it should remain in its original packaging until immediately before implantation, protected from contamination and environmental damage.
Does the PROLOG MP 658M Pulse Generator have any specific MRI compatibility considerations?
The PROLOG MP 658M Pulse Generator operates within MRI-safe parameters as defined by the manufacturer, but specific MRI compatibility should be verified pre-procedure to ensure patient safety. Always confirm the device’s compatibility with the intended MRI scan settings before use.
What regulatory pathway was followed for the commercialization of the PROLOG MP 658M Pulse Generator in the U.S.?
The PROLOG MP 658M Pulse Generator was authorized under FDA 510(k) clearance (K883087), following a traditional review process by the Cardiovascular (CV) Advisory Committee. It is classified as a Class III device under FDA regulations, requiring this pathway for commercialization.